Johnson & Johnson DePuy Synthes TRAUMA Titanium Cannulated Tibial... User manual

TITANIUM
CANNULATED
TIBIAL NAIL
Expert Nailing System
SURGICAL TECHNIQUE

Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique DePuy Synthes Trauma
INTRODUCTION
SURGICAL TECHNIQUE
PRODUCT INFORMATION
TABLE OF CONTENTS
Titanium Cannulated Tibial Nail Expert Nailing System 2
AO Principles 4
Indications 5
Clinical Cases 6
Preoperative Planning 8
Opening the Tibia 9
Reaming (optional) 14
Inserting the Nail 15
Locking Options 19
Locking Holes 20
Distal Locking 21
Proximal Locking 27
End Cap Insertion 41
Implant Removal 43
Implant Specifications 48
Implants 49
Instruments 56
Set Lists 61
Image intensifier control

2 DePuy Synthes Trauma Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique
IMPROVED STABILITY
ADVANCED SOLUTIONS
Advanced proximal locking options
xThree innovative locking options, in
combination with dual core locking
screws, to increase the stability of
the proximal fragment for proximal
third fractures
xTwo state-of-the-art mediolateral
(ML) locking options enable primary
compression or secondary controlled
dynamization
End caps
xGold end caps securely lock the most
proximal oblique locking screw to
create a fixed-angle construct
xGray end caps feature a lead-in
design for easier end cap insertion
xEnd caps prevent ingrowth of tissue
and facilitates nail extraction
xSelf-retaining T40 StarDrive recess for
easy pick up and insertion of end cap
xCannulated
x0 mm end caps sit flush with nail
x5, 10, and 15 mm end caps extend
nail height if nail is overinserted
TITANIUM CANNULATED TIBIAL NAIL
EXPERT NAILING SYSTEM
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StarDrive
T40
15 mm 10 mm 5 mm 0 mm
15 mm 10 mm 5 mm 0 mm

Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique DePuy Synthes Trauma 3
Advanced nail design
xAnatomic bend for ease of nail
insertion
xTitanium alloy* for improved
mechanical and fatigue properties
xCannulated nails (from 8 mm–13 mm
diameter) for reamed or unreamed
techniques, enabling nail insertion
over guide wire
xAll DePuy Synthes 2.5 mm or
3.0 mm ball tipped guide wires may
be removed through the nail and
insertion handle assembly (no
exchange tube required)
Advanced distal locking options
xDistal oblique locking options to
prevent soft tissue damage and
increase stability of the distal
fragment
xTwo ML and one anteroposterior
(AP) locking options for stability
of the distal fragment
All locking screws
xDouble-lead thread for more contact
points enhance stability and ease
of insertion
xThread closer to screw head provides
better bone purchase in the near
cortex and improved stability
xTitanium alloy* for improved
mechanical and fatigue properties
xSelf-tapping blunt tip
xSelf-retaining T25 StarDrive recess
allows improved torque transmission
and increased resistance to stripping
relative to a hex recess and secure
locking screw pick-up
Dual-core locking screws
xIndicated for the three proximal
locking options of all tibial nails
xDual-core design for optimized
purchase in cancellous bone
xUnicortical
xLengths: 30 mm–90 mm
Standard locking screws
xLarger cross-section for improved
mechanical resistance
x4.0 mm diameter for 8 mm and 9 mm
tibial nails, lengths: 18 mm–80 mm
x5.0 mm diameter for 10 mm–13 mm
tibial nails, lengths: 26 mm–100 mm
Titanium Cannulated Tibial Nail
Expert Nailing System
MULTIDIRECTIONAL LOCKING OPTIONS FOR IMPROVED STABILITY
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StarDrive
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*Titanium-6% aluminum-7% niobium alloy

4 DePuy Synthes Trauma Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique
AO PRINCIPLES
1. Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal
Fixation, 3rd Edition. Berlin: Springer-Verlag. 1991.
In 1958, the AO formulated four basic principles, which have
become the guidelines for internal fixation.1 They are:
Anatomic reduction
Fracture reduction and fixation to restore anatomical
relationships.
Stable fixation
Stability by fixation or splintage, as the personality
of the fracture and the injury requires.
Preservation of blood supply
Preservation of blood supply to soft tissue and bone
by careful handling.
Early, active mobilization
Early, active mobilization of the part and patient.

Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique DePuy Synthes Trauma 5
INDICATIONS
The Tibial Nail –EX is intended to stabilize fractures of the
proximal and distal tibia and the tibial shaft, open and closed
tibial shaft fractures, certain pre- and postisthmic fractures,
and tibial malunions and nonunions.

6 DePuy Synthes Trauma Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique
CLINICAL CASES
Shaft fracture
Case 1
For simple shaft fractures, two proximal ML and two distal
ML locking screws are normally sufficient to stabilize the
fracture. Secondary dynamization is achieved by removing
the proximal static locking screw.
Fracture involving the distal component
Case 2
The use of four distal locking screws is sometimes necessary
to achieve stabilization of the distal fragment. In many cases,
three locking screws placed in the most distal locking options
are sufficient to stabilize the distal fragment.
Note: Results from clinical cases are not predictive of results in other cases.
Results in other cases may vary.

Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique DePuy Synthes Trauma 7
Clinical Cases
Preoperative Follow-up (3 weeks after surgery)
Preoperative Follow-up (3 weeks after surgery) Postoperative
Intraoperative

8 DePuy Synthes Trauma Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique
PREOPERATIVE PLANNING
Use the AO preoperative planner template for the Tibial
Nail–EX to estimate nail diameter and nail length. To estimate
nail diameter, place the template on the AP or lateral x-ray
of the uninjured tibia and measure the diameter of the
medullary canal at the narrowest part that will contain
the nail.
To estimate nail length, place the template on the AP x-ray
of the uninjured tibia and select the appropriate nail length
based on patient anatomy. When selecting nail size, consider
canal diameter, fracture pattern, patient anatomy, and post-
operative protocol.
Note: Templates are available in two sizes: actual size
and 115% magnification in which the image is enlarged
15% to correspond to typical radiographic magnification;
however, variations in magnification levels are common.

Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique DePuy Synthes Trauma 9
2
Reduce fracture
Instrument
394.35* Large Distractor
Perform closed reduction manually by axial traction under
image intensification. The use of the large distractor may
be appropriate in certain circumstances.
Note: The reduction can be temporarily fixed with reduc-
tion clamps. In epiphyseal fractures the condyles or the
pilon are fixed first in order to enable the nail insertion.
OPENING THE TIBIA
1
Position patient
Position the patient supine on the radiolucent table. Ensure
that the knee of the injured leg can be flexed at least 90°.
Position the image intensifier so that visualization of the
tibia, including the articular surface proximally and distally,
is possible in AP and lateral views.
Optionally, the procedure can be performed on a fracture
table with the leg placed in traction.
Note: The knee roll can be placed under the lower part
of the thigh if it obstructs the view of the tibial plateau
in the AP view.
*Also available

10 DePuy Synthes Trauma Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique
Opening the Tibia
3
Confirm nail length and diameter
Instrument
03.010.021 Radiographic Ruler, for Titanium
Cannulated Tibial Nails –EX
The required nail length must be determined after reduction
of the lower leg fracture.
Position the C-arm for an AP view of the distal tibia. With
long forceps, hold the radiographic ruler along the leg,
parallel to and at the same level as the tibia. Adjust the ruler
until the distal tip is at the level of the physeal scar or the
desired nail insertion depth. Mark the skin at that site.
Move the C-arm to the proximal tibia, replace the distal end
of the ruler at the skin mark, and take an AP image of the
proximal tibia. Read nail length directly from the ruler image,
selecting the measurement at or just below the level of the
anterior edge of the tibial plateau.
When using the large distractor, measure the distance from
the inferior border of the distal pin to the superior border of
the proximal pin to determine optimal nail length.
Position the C-arm for an AP or lateral view of the tibia at
the level of the isthmus. Hold the radiographic ruler over
the tibia so that the diameter gauge is centered over the
narrowest part of the medullary canal. Read the diameter
measurement on the circular indicator that fills the canal.
Note: Compression or dynamization must be taken into
account when determining the nail length. A shorter
nail should be chosen when active compression is
planned for the procedure. The dynamic locking option
allows for 7 mm of travel.
Important: The ruler is not at the same level as the
tibia. This affects the accuracy of the measurement,
providing only an estimate of the canal diameter.

Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique DePuy Synthes Trauma 11
Opening the Tibia
4
Approach
Make an incision in line with the central axis of the
intramedullary canal. Depending on the anatomy of the
patient, this incision can be transpatellar, medial or even
lateral parapatellar.
The incision starts proximally at the distal third of the patella
along the patellar ligament down to the tibial tuberosity.
Mobilize the infrapatellar corpus adiposum laterally and
dorsally without opening the synovia. Free access of the nail
to the insertion point must be guaranteed.
Prepare the entry site of the nail on the ventral edge of the
tibial plateau.
5
Determine entry point
The entry point defines the optimal position of the nail in the
intramedullary canal. This is more important for proximal and
distal-third fractures to prevent fragment displacement.
In AP view, the entry point is in line with the axis of the
intramedullary canal and with the lateral tubercle of the
intercondylar eminence.
In lateral view, the entry point is at the ventral edge of the
tibial plateau.
10°

12 DePuy Synthes Trauma Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique
Opening the Tibia
6
Insert guide wire
Instrument
357.399 3.2 mm Guide Wire, 400 mm
Slightly punch mark the insertion point at a 10° angle to
the shaft axis in the lateral view.
Hold a sterile nail on the side of the lower leg with its distal
end parallel to the tibia shaft. The curved proximal nail end
determines the angle of insertion for the guide wire.
Insert the guide wire for approximately 8 cm–10 cm and
check the position under image intensification in the AP
and lateral views.

Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique DePuy Synthes Trauma 13
Opening the Tibia
7
Open medullary canal
Instruments
03.010.035 12.0 mm Protection Sleeve
03.010.036 12.0 mm Cannulated Drill Bit, large quick
coupling, 190 mm
357.399 3.2 mm Guide Wire, 400 mm
Place the protection sleeve and the drill bit over the guide
wire and down to the bone. Drill to a depth of approximately
8 cm–10 cm. The guide wire and the drill bit should not
touch the posterior cortex.
Remove the guide wire, drill bit, and protection sleeve.
Note: Dispose of the guide wire. Do not reuse.
Alternative instruments
03.010.040 12.0 mm Cannulated Awl
357.399 3.2 mm Guide Wire, 400 mm
Place the cannulated awl over the guide wire and open
the medullary canal. Use a twisting motion to advance the
awl to a depth of approximately 8 cm–10 cm.
The awl should not touch the posterior cortex.
Remove the guide wire and awl.
Note: Dispose of the guide wire. Do not reuse.

14 DePuy Synthes Trauma Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique
REAMING (OPTIONAL)
8
Reaming medullary canal (optional)
Instruments
03.010.024 Holding Device, for Guide Wires
and Reaming Rods
03.010.093 Reaming Rod Push Rod
351.706S* 2.5 mm Reaming Rod with ball tip,
950 mm, sterile
351.707S* 2.5 mm Reaming Rod with ball tip and
extension, 950 mm, sterile
Also available set
150.060 Flexible Reamer Set for IM Nails
If necessary, enlarge the tibial canal with the medullary
reamer, to the desired diameter.
Check fracture reduction under the image intensification.
Inserting the reaming rod
Insert the reaming rod with ball tip into the medullary canal,
using the holding device to the desired insertion depth.
Reaming
Starting with the 8.5 mm diameter reaming head, ream
to a diameter of 0.50 mm–1.0 mm greater than the nail
diameter. Ream in 0.5 mm increments and advance the reamer
with steady, moderate pressure. Do not force the reamer.
Partially retract the reamer often to clear debris from the
medullary canal.
Note: All nails in the cannulated Tibial Nail Expert
System can be inserted over the reaming rod with ball
tip. Reaming rod exchange is not required.
Option
Use the reaming rod push rod to help retain the reaming
rod during reamer extraction.
*Also available

Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique DePuy Synthes Trauma 15
INSERTING THE NAIL
1
Assemble insertion instruments
Instruments
03.010.044 Cannulated Connecting Screw,
for Standard Insertion Handle
03.010.045 Standard Insertion Handle
03.010.092 Ball Hex Screwdriver, 8 mm
Orient the insertion handle anteriorly, and match the tang
on the handle to the notch in the nail.
Place the connecting screw into the insertion handle and
thread it into the proximal nail end, using the 8 mm ball
hex screwdriver.
Verify the nail is oriented properly on the insertion handle;
secure the assembly with the 8 mm ball hex screwdriver.
Alternative instruments
03.010.017 Tibial Nail–EX Insertion Handle
03.010.145 Cannulated Connecting Screw, for Short
Insertion Handle, with internal thread
or
03.010.046 Percutaneous Insertion Handle
03.010.146 Cannulated Connecting Screw, for
Percutaneous Insertion Handle, with
internal thread
Optional instrument
03.010.093 Reaming Rod Push Rod
Optionally, slide the connecting screw onto the reaming
rod push rod. Slide the assembly through the insertion handle
and match the tang of the handle to the notch of the nail.
Tighten, using the hex on the reaming rod push rod.
Secure the assembly using the 8 mm ball hex screwdriver.

16 DePuy Synthes Trauma Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique
Inserting the Nail
2
Insert nail
Note: Hyperflex the knee to aid nail insertion into the
medullary canal.
Insert the nail into the intramedullary canal. Use a twisting
motion to advance the nail.
Monitor the nail passage across the fracture; control in two
planes to avoid malalignment.
Insert the nail until it is at or below the tibial opening.
Check final nail position in AP and lateral views.
Note: For proximal locking, mount the aiming arm
only when the tibial nail has been completely inserted,
otherwise the aiming arm may loosen during nail
insertion.
Optional instruments
03.010.047 Driving Cap
03.010.056 Slide/Fixed Hammer, 700 grams
321.17 4.5 mm Pin Wrench
321.20 11 mm Ratchet Wrench
357.22 Hammer Guide, for Slide Hammer
357.398 Cannulated Shaft with 8 mm hex
If needed, use light, controlled hammer blows to seat the
nail. Slide the driving cap into the grooves on the insertion
handle and secure it, using the 11 mm wrench. Lock the
head of the hammer in place by tightening the nut onto the
threads located below the hammer head, using the 4.5 mm
pin wrench. Strike the driving cap directly.
Optionally, the hammer guide can be threaded into the
driving cap and the hammer can be used as a slide hammer.
Loosen the nut from the threads located below the hammer
head and secure onto the threads located above the handle.

Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique DePuy Synthes Trauma 17
Inserting the Nail
Note: If nail insertion is difficult, choose a smaller
diameter tibial nail or ream the medullary canal to a
larger diameter.
Important: Confirm that the nail is securely connected to
the insertion handle, especially after hammering, using
either the 8 mm ball hex screwdriver or the cannulated
shaft with 8 mm hex.
Important: Do not strike the insertion handle directly.
3
Check proximal nail position
Instruments
03.010.052 Aiming Arm, for Titanium Cannulated
Tibial Nails–EX
357.399 3.2 mm Guide Wire, 400 mm
Attach the aiming arm and insert a 3.2 mm guide wire
through the hole as shown in the illustration.
The tip of the guide wire indicates the exact proximal
position of the tibial nail.
Remove the driving cap.
Remove the aiming arm, unless proximal locking is the
next step.
Check proximal nail position under image intensification
in the lateral view.
Note: The distance between the markings on the insertion
handle is 5 mm and corresponds to the extensions of the
end caps. This feature can be used for overinsertion of
the nail or for correcting the nail location within the
medullary canal.
If primary compression or secondary dynamization are
planned, it is recommended to overinsert the nail by more
than 7 mm, which corresponds to the maximum distance
between the positions in static and dynamic modes.
20 mm
15 mm
10 mm
5 mm
0 mm

18 DePuy Synthes Trauma Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique
Inserting the Nail
4
Check distal nail position
Check final nail position under image intensification in
AP and lateral views.
Remove the reaming rod.
Important: Confirm that the nail is securely connected to
the insertion handle, especially after hammering, using
either the 8 mm ball hex screwdriver or the cannulated
shaft with 8 mm hex.
Note: Insertion depth is critical for distal third fractures
where a minimum of two locking screws below the
fracture line are required to stabilize the distal segment.

Titanium Cannulated Tibial Nail Expert Nailing System Surgical Technique DePuy Synthes Trauma 19
LOCKING OPTIONS
Proximal segment fractures
For proximal fractures, it is recommended to lock the nail
with the knee in extension. This neutralizes the deforming
forces on proximal fragments caused by the quadriceps
mechanism, and relieves the pressure on the soft tissue
usually associated with tibial nail insertion instruments. This
position also facilitates assessment of rotational alignment
before locking.
Diaphyseal segment fractures
For diaphyseal fractures, it is recommended to lock distally
first, to allow intraoperative compression.
Distal segment fractures
For distal fractures, it is recommended to lock distally first,
to facilitate reduction.