Orthofix External Fixation System User manual

PQ EXF S 08/19
0123
ORTHOFIX Srl
Via Delle Nazioni 9 - 37012 Bussolengo (Verona) - Italy
Telephone [phone] - Fax [phone]
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ORTHOFIX® EXTERNAL FIXATION SYSTEM
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SISTEMA DI FISSAZIONE ESTERNA ORTHOFIX®
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SYSTEME DE FIXATION EXTERNE ORTHOFIX®
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ORTHOFIX® SYSTEM ZUR EXTERNEN FIXATION
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SISTEMA DE FIJACIÓN EXTERNA ORTHOFIX®
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ORTHOFIX® EXTERN FIXATIONSSYSTEM
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ULKOINEN KIINNITYSJÄRJESTELMÄ ORTHOFIX®
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ORTHOFIX® UTVENDIG FESTESYSTEM
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ORTHOFIX® SYSTEEM VOOR EXTERNE FIXATIE
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SISTEMA DE FIXAÇÃO EXTERNA ORTHOFIX®
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ORTHOFIX® EXTERNA FIXERINGSSYSTEM
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ΣΥΣΤΗΜΑ ΕΞΤΕΡΙΚΗΣ ΣΤΑΘΕΡΟΠΟΙΗΣΗΣ ORTHOFIX®
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フィックス創外固定システム
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ORTHOFIX®外固定支架系统
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ZEVNÍ FIXAČNÍ SYSTÉM ORTHOFIX®
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SYSTEM STABILIZACJI ZEWNĘTRZNEJ ORTHOFIX®
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ORTHOFIX® SISTEM ZA ZUNANJO FIKSACIJO
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ORTHOFIX ® 외부 고정 기구
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ORTHOFIX®     
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„ ORTHOFIX®“ IŠORINĖ FIKSAVIMO SISTEMA
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SISTEM FIKSASI LUARAN ORTHOFIX
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SISTEMUL DE FIXARE EXTERNĂ ORTHOFIX®
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ORTHOFIX® EXTERNAL FIKSASYON SISTEMI
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®ORTHOFIX    
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PQ EXF S 08/19 Instructions For Use are subject to change; the most current version of each Instruction For Use is always available online.
EN Important information - please read prior to use
ORTHOFIX®EXTERNAL FIXATION SYSTEM
Manufacturer name
ORTHOFIX SRL, via Delle Nazioni 9, 37012 Bussolengo (VR) Italy
Tel. [phone] - Fax [phone]
DESCRIPTION & INDICATIONS FOR USE
The Orthofix External Fixation System consists of a series of monolateral or circular external fixators intended to be used in conjunction with Orthofix bone screws, threaded wires or Kirschner wires and the Fragment Fixation
System. These devices are intended as a means to stabilize bone segments in a broad range of indications, including fractures, joint fusion, joint distraction, bone transport, lengthening and angular corrections. Fragment
Fixation System Implants are indicated in fractures, bony ligament avulsions, osteotomies. The Orthofix External Fixation System components are not intended to replace normal healthy bone or to withstand the stresses of full
weightbearing, particularly in unstable fractures or in the presence of non union, delayed union or incomplete healing. The use of external supports (e.g. walking aids) is recommended as a part of the treatment. The system
consists of various modules to be applied in different anatomical sites, i.e. tibia, femur, pelvis, humerus, forearm, hand and foot. When used correctly, the Orthofix External Fixation System maintains limb function, minimizes
surgical trauma to anatomical structures, preserves the blood supply and osteogenic potential of the tissues, and where indicated, provides for the application of dynamization to enhance the fracture healing process. All Orthofix
devices are intended for professional use only. Surgeons who supervise the use of Orthofix devices must have full awareness of orthopaedic fixation procedures as well as adequate understanding of the philosophy of the Orthofix
modular system. To promote the proper use of its fixation system, and establish an effective promotional and training tool, Orthofix has developed several manuals or CD-ROM’s containing the relevant information (i. e. general
philosophy, surgical application, etc.) called “Operative Techniques”. These are available in several languages as a complimentary service for surgeons who have adopted the Orthofix system. If you wish to receive a personal copy,
please contact Orthofix or its local authorized representative, with a description of the medical device to be used.
CONTRAINDICATIONS
The Orthofix External Fixation System is not designed or sold for any use except as indicated.
Use of the system is contraindicated in the following situations:
- Patients with mental or physiological conditions who are unwilling or incapable of following postoperative care instructions.
- Arthrodiatasis of the hip utilizing Orthofix external fixation in inflammatory arthropathies and for patients over the age of 45 years.
- Patients with severe osteoporosis, patients who are HIV positive and patients with severe, poorly controlled diabetes mellitus.
- Patients with foreign body sensitivity. Where material sensitivity is suspected, tests should be made prior to implant insertion.
WARNINGS & PRECAUTIONS
1. Compression is never recommended in a fresh fracture.
2. Axial displacement may occur if the body of the fixator is not in line with and parallel to the bone.
3. Medial or lateral translation may occur if the body of the fixator is not placed parallel to the diaphysis.
4. Particular care should be taken that screws do not enter the joints or damage the growth plates in children.
5. Dynamization and physical therapy guidelines should be followed based on each individual case and the fixation system used, and should be instituted as and when considered appropriate by the surgeon, in accordance with
clinical and radiological findings.
6. Any device implanted into the patient, such as bone screws, threaded wires, Kirschner wires, Fragment Fixation System implants, and in
general any device which is labelled “single use only”, including cams and bushes of any external fixation device, MUST NOT BE RE-USED.
7. Screw length and thread length should be selected in accordance with bone and soft tissue dimensions. The screw thread is conical in design and tapers, for example, from 6.0 to 5.0mm between the shaft and the tip of the
standard Orthofix screws, or from 6.0 to 5.6mm in the
XCaliber® screws. Thread length should be such that at least one full thread will remain outside the entry cortex and the screw tip will project just beyond the second cortex. Screw thread lengths are provided in increments
of 10mm, so that no more than 10mm of thread should be exposed outside the entry cortex. Excessive penetration of the second cortex by any type of screw should be avoided, because of the risk of soft tissue damage. Bone
screws should never be inserted so that the smooth shank penetrates the entry cortex, because of the risk of damage to the bone.
8. Due to the conical thread design, any attempt to back out an Orthofix screw once it has been inserted may cause it to become loose.
9. Screw diameter should be selected in accordance with bone diameter: for a bone diameter greater than 20mm, 6-5 or 6-5.6mm bone screws should be used; for a bone diameter between 12 and 20mm, 4.5-3.5mm bone
screws; and for a bone diameter between 9 and 12mm, 3.5-3.2mm bone screws should be used.
10. For pre-drilled bone screws, pre-drilling with appropriate drill bits and drill guides prior to screw insertion is imperative. Matching grooves on screws and drill bits help the surgeon to use the correct drill bit. Blunt drill bits can cause
thermal damage to the bone and should always be discarded.
11. Self-drilling screws with a thread diameter of 5.00mm or above should never be inserted with a power tool, but always by hand or with a hand drill. Self-drilling screws with smaller thread diameters may be inserted with a
power drill at low speed.
12. When cutting the XCaliber bone screws, they should either be cut before insertion, or after they have all been inserted, the fixator applied and the clamp locking screws firmly tightened. They should never be cut after insertion
before the fixator is applied, because some of the cutting force may be transferred to the bone.
13. The XCaliber bone screws are designed to be self-drilling, and direct insertion with a hand drill is advised in most cases. However, when insertion of self-drilling screws is performed in diaphyseal bone, pre-drilling is
recommended; use a 4.8mm drill bit through a drill guide when the bone is hard; when the bone quality is poor, or in the metaphyseal region where the cortex is thin, a 3.2mm drill bit should be used. Screw insertion, whether
or not pre-drilling has been performed, should always be with the hand drill or T-Wrench only. It is important that moderate force is applied for the screw to gain entry into the first cortex. Insertion can be completed with the
T-wrench. Diaphyseal bone screws should always be inserted in the centre of the bone axis, to avoid weakening it. In all cases the surgeon should be mindful of the amount of torque required to insert the screw. If it seems
tighter than usual, it is safer to remove the screw and clean it, and drill the hole again with a 4.8mm drill bit, even if it has already been used.
14. Transfixing pins of 4mm in diameter are self-drilling and may be inserted with a power drill. These pins are used in association with the
Prefix Fixator for temporary ligamentotaxis of the ankle and knee. After insertion they should be cut and the ends protected so that the patient cannot be injured on the opposite leg. Orthofix Transfixing pins are single use
devices and should never be re-used. They are connected to the Prefix Bars with two Transfixing Pin Clamps.
15. When screws are to be held in one of the range of 3 or 5 seat screw clamps, it is very important that they are inserted with the correct
procedure, so that they are parallel when in position. This is achieved by using screw guides in the templates or fixator clamps provided, and pre-drilling the screw hole, when required, through the correct size of drill guide. The
clamps should be tightened so that the screw guides are gripped evenly, and held in correct relationship to each other.
16. When screws are inserted into one of the fixator clamps, in such a way that one of the screw seats at the end of the clamp is empty, it is
important that this is filled with a short, dummy screw, so that the clamp cover grips all the screws with an equal pressure.
17. The T-Clamp of the XCaliber External Fixator allows for either parallel or convergent positioning of the proximal screws. When using the
T-clamp, the first screw to be inserted should always be in the screw seat which is part of the fixed straight clamp; subsequent screws should be in the converging section of the T-clamp. When the convergent mode is used,
the fixator should be positioned at the correct distance from the bone before inserting the second screw, as the fixator will not slide along convergent screws.
18. For more stable fixation of a fracture with a fixator, we recommend that the nearest bone screw is applied fairly close to the fracture margin (a minimum of 2 cm is recommended) and that these distances are equal on both
sides of the fracture. The supplementary screw holder (10037 or 91037) is supplied to achieve this.
19. When unusually high loading conditions are likely, such as weightbearing with a femoral application or when the patient is very heavy, before the ball joints are locked the fixator body should be aligned so that the body locking
nut is at 90 degrees to the plane of the screws. In
addition for increased stability the compression-distraction unit may be applied to the fixator body and locked into place.
20. Threaded wires and Fragment Fixation System Implants are drilled directly into the bone, and have a cylindrical thread which allows them to be backed out following insertion. When the chamfer of the Fragment Fixation
Implant is close to the cortex, the speed of insertion must be reduced.
21. No attempt should be made to insert a Kirschner wire more than once; since the tip may have become blunt and is the only cutting surface, undesirable heating of the bone may occur.
22. Appropriate Orthofix instrumentation should be used to insert bone screws and Kirschner wires correctly.
23. Wherever a Kirschner wire or Guide Wire is used to guide a cannulated reamer, drill bit or screw into position:
a) The Kirschner or Guide Wire should always be NEW.
b) The wire should be checked before insertion to exclude any scratches or bends.
c During the introduction of any instrument or implant over a wire, the surgeon should screen the wire tip as continuously as possible to exclude inadvertently driving the wire further than intended.
d) During each pass of the instrument or implant, the surgeon should check that there is no bony or other debris built up on the wire or
inside the instrument or implant which might cause it to bind on the wire and push it forward.
24. It is impossible to clean the inside of a cannulated drill bit adequately to exclude organic or other debris remaining after use.
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CANNULATED DRILL BITS SHOULD THEREFORE NEVER BE REUSED. THEY ARE SINGLE PATIENT USE ONLY.
If a cannulated drill bit is to be used for a second time on the same patient, the surgeon must check that the drill bit is free from obstruction, by removing it from the power unit and passing a wire through it.
25. Even when a cannulated drill bit is new, we recommend that a wire is passed through it prior to use, to check that the lumen is free from
obstruction.
26. To tension Kirschner wires, the handle of the wire tensioning device should be opened to the fullest extent and the device fully inserted over the wire against the face of the slider unit, ensuring that at least 6 cm of wire
protrudes from the tensioning device.
27. Wires mounted on full Sheffield rings should be tensioned to a minimum of 1200N.
Tension should be reduced to 800-1000N when Kirschner wires with a central olive are used to stabilize a fragment.
When the Foot Ring 81500 is being used, tensioning is reduced depending on the position of the hole being used. If hole no. 1 is at the end of each limb of the Foot Ring, the suggested maximum wire tensions are as follows:
holes 1-3: 500N, holes 4-7: 700 N, holes 8-11: 1000N, holes 11-17: 1200N, beyond hole 17: as in a circular ring.
Tension should also be reduced to between 600 and 800N when wires are applied away from the ring.
When the Hinge Clamp is being used to position an oblique wire away from the ring, excessive tension may cause the locked hinge to slip. Tensioning should cease if bending of the clamp is noted. While tightening the wire
clamp screw, it is important not to lever the wire
tensioning device, which might cause breakage of the Kirschner wire.
28. In case aTrueLok-Hex ring is used for a hybrid frame, refer to instructions available in leaflet PQTLK, (PQTLH) and PQWTN.
29. The slotted washer can be used in a variety of positions in association with a ring fixator. The amount of tension possible with this device depends on its distance from the ring, up to a maximum of 1000 Newtons. When it is
attached directly to a ring, care should be taken to hold the tensioner level when in use to avoid kinking and damage to the wire.
30. All equipment should be carefully examined prior to use to assure proper working condition. If a component or instrument is believed to be faulty, damaged or suspect, it should NOT BE USED. Hybrid Fixation Frames for use in
progressive deformity correction should be
pre-assembled and tested prior to application to ensure that they will provide the desired correction and that the hinges are at the correct level.
31. The fixator should be applied at a sufficient distance from the skin to allow for post-operative swelling and for cleaning, remembering that the stability of the system depends upon the bone-fixator distance. If the fixator is sited
at a distance of more than 4 cm from the bone, the use of 3 screws per clamp is advisable.
32. Final locking of the ball-joints of the 10000, 30000/31000 or 90000 range of fixators is performed with a torque wrench, which must be turned in a clockwise direction only. A click indicates that the correct torque has been
applied. Any attempt to unlock the cam or any screw using the torque wrench will damage its gearing. The torque wrench is pre-set at a specific value, which is 15 Nm±0.5 for the 30000/31000 Range (30025) and 27 Nm±1
for the 10000 and 90000 Ranges (10025). This value should be checked at least every two years or any time the
instrument becomes damaged, by returning it to the local authorized representative. The cams and bushes in the ball joints of the 10000, 30000, 31000 and 90000 range of fixators must be replaced after every use. Note: If on
tightening the cams and bushes with the torque wrench, the mark on the cam moves more than 170° from the fully unlocked position, all cams and bushes must be replaced. If the problem persists, the whole fixator should be
replaced. The use of a torque wrench is not required for final locking of the ball joints in the XCaliber External Fixator. Final locking is achieved with the Allen Wrench. The cams can be locked from either side of the clamp. They
should be turned towards the thicker section of the coloured insert until tightly closed, and the cam is at least 50% of the way across the recess.
33. The 30000 fixator is only indicated in the upper limb. The 31000 Fixator is indicated in the upper limb and in the lower limb for patients weighing less than 45 Kg (100 pounds).
34. Components may not be interchangeable between all Orthofix external fixation systems. Consult individual operative technique guides for interchangeable components. In particular, it is not suitable for use with the older rings
of the 80000 series.
35. When an unstable fracture is treated with the Hybrid fixator, reinforcement bars should be used.
36. Additional equipment may be required for fixation application and removal such as wire cutters, mallet and power drill.
37. Screw and frame integrity should be monitored at regular intervals.
38. Meticulous screw or wire site hygiene is required.
39. All patients must receive instruction on the use and maintenance of their fixator, and on pin site care.
40. Patients should be instructed to report any adverse or unanticipated effects to the treating surgeon.
41. The fracture site gap should be reassessed periodically during healing, and adjustments to the frame made as necessary. Persistent
separation of the fracture ends may lead to delay in bone union.
42. In patients undergoing distraction osteogenesis, the rate of distraction (usually 1mm per day, i.e. 1/4 turn of the compression-distraction unit every six hours) should be controlled and adjusted in accordance with the rate of
ossification, monitored radiologically.
43. Removal of the device: the surgeon should make the final decision whether a fixation device can be removed.
44. Do not use components of the Orthofix External Fixation Systems in conjunction with products of other manufacturers, unless otherwise
specified, as the combination is not covered by the necessary validation.
45. Products that show excessive fading of marked product code and lot, thus preventing clear identification and traceability, must NOT BE USED.
POSSIBLE ADVERSE EFFECTS
1. Nerve or vessel damage resulting from insertion of wires and screws.
2. Superficial or deep bone screw tract infection, osteomyelitis, or septic arthritis, including chronic drainage of bone screw sites after device removal.
3. Oedema or swelling; possible compartment syndrome.
4. Joint contracture, subluxation, dislocation or loss of range of motion.
5. Premature bone consolidation during distraction osteogenesis.
6. Possible tension to soft tissues and/or frame during callus manipulation (i.e. correction of bony deformity and/or bone lengthening),
7. Failure of bone to regenerate satisfactorily, development of nonunion or pseudarthrosis.
8. Fracture of regenerate bone or through bone screw holes after device removal.
9. Loosening or breakage of the bone screws.
10. Bony damage due to inappropriate bone screw selection.
11. Bone deformity or equinus of the foot.
12. Persistence or recurrence of the initial condition requiring treatment.
13. Reoperation to replace a component or entire frame configuration.
14. Abnormal growth plate development in patients who are skeletally immature.
15. Foreign body reaction to bone screws or frame components.
16. Tissue necrosis secondary to bone screw insertion.
17. Pressure on the skin caused by external components when clearance is inadequate.
18. Limb length discrepancy.
19. Excessive operative bleeding.
20. Intrinsic risks associated with anesthesia.
21. Intractable pain.
22. Bone sequestration secondary to rapid drilling of bony cortex with heat build-up and bone necrosis.
23. Vascular disorders including thrombophlebitis, pulmonary embolus, wound hematomas, avascular necrosis.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Important
A successful result is not achieved in every surgical case. Additional complications may develop at any time due to improper use, medical reasons or device failure which require further surgical intervention to remove or replace
the external fixation device. Preoperative and operative procedures including knowledge of surgical techniques and proper selection and placement of the external fixation devices are important considerations in the successful
utilization of Orthofix external fixation devices by the surgeon. Proper patient selection and the patient’s ability to comply with physician instructions and follow prescribed treatment regimen will greatly affect the results. It is
important to screen patients and select optimal therapy given physical and/or mental activity requirements and/or limitations. If a surgical candidate exhibits any contraindications or is predisposed to any contraindications, DO NOT
USE Orthofix external fixation devices.
MRI SAFETY INFORMATION
Unless otherwise stated in product-specific additional instructions for use, the following statements apply:
• The Orthofix External Fixation System has not been evaluated for safety and compatibility (i.e. heating, migration, or image artifact) in the MR environment;
• The Orthofix External Fixation System safety in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

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Materials
The Orthofix External Fixation System is comprised of stainless steel, aluminium alloy and plastic components. Those components which contact the patient are the percutaneous pins (bone screws), K-wires, drill bits, guides used
during screw insertion, trocars and bone depth gauges. These are manufactured from surgical grade stainless steel. Some of the Orthofix external fixation bone screws (pins) are supplied with a thin, plasma sprayed coating of
hydroxyapatite (HA) on the threaded portion of the shaft.
STERILE & NON-STERILE Product
Orthofix provides certain external fixation devices STERILE while others are provided NON-STERILE.
Please review the product label to determine the sterility of each device.
Sterile
Devices or kits provided STERILE are labeled as such.
Contents of package are STERILE unless package is opened or damaged. Do not use if package is opened or damaged.
Non-Sterile
Unless otherwise noted, Orthofix external fixation components are provided NON-STERILE. Orthofix recommends that all NON-STERILE
components be properly cleaned and sterilized following the recommended cleaning and sterilization procedures.
Product integrity and performance are assured only if packaging is undamaged.
Cleaning & Maintenance (Attention, see instructions PQ ISP)
Prior to use, NON-STERILE product must be cleaned using a mixture of 70% medical grade alcohol and 30% distilled water. After cleaning, the device and/or system components should be thoroughly rinsed in sterile distilled water
and dried using clean non-woven fabric. Lubricate all parts, except for cam, bush and ball-joint coupling with lubrication oil for medical applications whenever required (see detailed Operative Technique Manuals). If the fixator is of the
reusable type, after it has been removed from the patient, it should be disassembled completely, cams and bushes discarded and all components cleaned using either 12 vol. hydrogen peroxide or a recommended detergent. To prevent
corrosion, the components must be kept dry, and detergents with fluoride, chloride, bromide, iodide or hydroxyl ions must be avoided when cleaning, as they will damage the black anodised coating on any Orthofix products, and this may
initiate the process of stress corrosion. Before sterilization, all components should be inspected, since damage to the surface of metal components can reduce strength and fatigue resistance, and may lead to corrosion. If components are
damaged in any way, they should be exchanged immediately for new ones. Assembly of the fixator should then be carried out to ensure that all components are present.
Note: cams and bushes are for SINGLE USE ONLY on all fixators. They MUST be discarded and replaced every time a fixator is cleaned after use and prior to sterilization.
ANY DEVICE WHICH IS LABELLED “SINGLE USE ONLY” MUST NEVER BE REUSED. ORTHOFIX IS ONLY RESPONSIBLE FOR
SAFETY AND EFFECTIVENESS FOR THE FIRST PATIENT USE OF SINGLE USE DEVICES. The institution or practitioner bears full responsibility for any subsequent use of these devices.
Sterilization
The recommended, validated sterilization cycle is:
Method Cycle Temperature Exposure Time
Steam Pre-Vacuum 132° - 135°C [270° - 275°F] Minimum 10 minutes
The fixator should be sterilized in the assembled state, but the ball-joints, central body locking nuts and clamp locking screws MUST BE left untightened. Sterilisation of the fixator with one or more joints locked is highly likely to
cause cracking. Sterility cannot be assured if the sterilization tray is overloaded. Do not overload the sterilization tray or include additional implants or instruments from any source.
Orthofix is only responsible for safety and effectiveness for the initial patient use of the external fixation devices. The institution or practitioner bears full responsibility for any
subsequent use of the devices.
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.
External Fixation Frames
which use Rings and Tensioned Wires
WIRE INSERTION
When Kirschner wires are inserted for use with a ring based frame, whether hybrid or a full circular frame:
a) They should be inserted from the side where the soft tissues are at most risk
b) They should be tapped through the soft tissues and drilled through the bone; they should never be drilled through soft tissues
c) They should be inserted with full knowledge of the safe corridors to avoid damage to the vital structures (see operating manuals 12 (a), (b) and (c)
d) A wire that has been inserted once should always be discarded if it is removed before tensioning (the tip may have become blunt and is the only cutting surface, so undesirable heating of the bone may occur)
e) Wire ends should be protected so that the other limb is not injured, either with covers firmly mounted, or by bending the ends over towards the ring.
HYBRID OR FULL RING FRAMES
a) When a single ring frame is used in conjunction with a fixator (hybrid) the ring should initially always be supported by 2 evenly spaced reinforcement bars, spaced around the ring and attached to the bone screws at the other
end of the fixator. If the fracture is stable, so that full load sharing is possible, the bars should be removed as soon as the patient is mobilised and the soft tissue swelling has decreased. If the fracture is unstable, the bars should
be retained while the patient is mobilising weightbearing. They should not be removed until the bone is sufficiently consolidated to share the axial load, but they should be removed as part of a dynamisation process before the
fixator is removed.
b) Where necessary, a supplementary bone screw should be used to equalise the distance between the fracture and the nearest fixation point on both sides.
c) During screw insertion, when using a Half Pin Fixation Bolt (part number 80076) care should be taken to avoid the soft tissues becoming attached to the screw, because this component cannot be used with a screw guide.
d) When assembling a 2 or 3 ring circular frame, the following points should be considered:
1) Ring connecting bars should be spaced as evenly as possible around the rings. Normally 3 are sufficient. If 4 are used, care should be taken that excessive vertical loads are not transmitted to the ring by uneven alteration of
the length of the connecting bars.
2) Sheffield rings should be assembled so that the 1/3 components, or the spaces where a 2/3 ring is used alone, are above each other.
3) The space in a Sheffield 2/3 ring, or the 1/3 component of a complete ring, should always be positioned posteriorly.
4) A Sheffield Clamp should always be positioned on the 2/3 component of a Sheffield ring.
5) Ideally all rings should be the same size; the frame should be applied so that the whole leg, not just the bone, is in the centre of the ring, and it is possible to insert two fingers between ring and soft tissues for the full
circumference.
6) Each ring should be at 90 degrees to the axis of the bone segment to which it is applied.
7) For ideal stability in all planes, there should be an angle between the outer two wires (crossing angle) of about 60 degrees. This is achieved if there are 7 empty holes between the fixation points on the ring.
8) Each bone segment should be supported by 3 or 4 tensioned wires, which can all be mounted on one ring.
9) For an appropriate usage of ProCallus Fixator Hybrid Connection, only TL-HEX rings must be applied.
e) Patient is allowed inital toe-touch weight bearing. Progressive weight bearing and physiotherapy should be established, according to the surgeon’s evaluation of the fracture stability and of the information derived from
radiological assessment.
CAUTION
When the normal sensation of the limb is disturbed, so that the patient will not receive the normal proprioceptive feedback, any fixation system may be subject to above normal loads. In such circumstances the patient should
be warned about the risk of excessive loading of the fixation device, and the physician should be on the lookout for particular problems related to excessive loading, such as loosening, bending or breakage of components. It is
recommended in these situations that the fixation system is constructed to be more robust that might otherwise be required.

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Symbol Description
Consult instructions for Use CAUTION: Consult instructions for use for important cautionary
information
Single use. Do not reuse
STERILE. Sterilised by irradiaton
NON STERILE
Catalogue number Lot number
Expiry date (year - month - day)
0123 CE marking in conformity to applicable European Directives/Regulations
Date of manufacture Manufacture
Do not use if package is opened or damaged
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician
All Orthofix internal and external fixation products should be used together with their corresponding Orthofix implants, components and accessories.Their application should be performed with the specific Orthofix instrumentation,
following carefully the surgical technique recommended by the manufacturer in the appropriate OperativeTechnique Manual.