Synthes TFN User manual

TFN – Titanium Trochanteric Fixation
Nail System. For intramedullary
fixation of proximal femur fractures.
Technique Guide
Instruments and implants
approved by the AO Foundation.
This publication is not intended for
distribution in the USA.

Image intensifier control
Warning
This description alone does not provide sufficient background for direct use of
the instrument set. Instruction by a surgeon experienced in handling these
instruments is highly recommended.
Processing, eprocessing, Care and Maintenance
For general guidelines, function control and dismantling of multi-part instruments,
as well as processing guidelines for implants, please contact your local sales
representative or refer to: www.synthes.com/reprocessing
For general information about reprocessing, care and maintenance of Synthes
reusable devices, instrument trays and cases, as well as processing of Synthes
non-sterile implants, please consult the Important Information leaflet (SE_023827)
or refer to: www.synthes.com/reprocessing

Table of Contents
Introduction
Surgical Technique
Product Information
TFN – Titanium Trochanteric Fixation Nail System 2
Biomechanical Features 3
AO Principles 6
Indications 7
Clinical Cases 8
Preoperative Implant Selection 9
Open Proximal Femur 10
Insert Nail 17
Proximal Locking 21
Distal Locking – Short Nails 35
SureLock Distal Targeting Device – Long Nails 39
Freehand Distal Locking – Long Nails 40
Insert End Cap 44
Implant emoval 45
Instrument Cleaning 54
Locking Mechanism Assembly 55
Implants 56
– For Titanium Cannulated Trochanteric Fixation Nails 56
– Titanium Trochanteric Fixation Nails (green) – Short 59
– Titanium Trochanteric Fixation Nails (green) – Long 61
Instruments 64
Sets 73
Also Available 77
Titanium Trochanteric Fixation Nail System Technique Guide Synthes 1

2 Synthes TFN – Titanium Trochanteric Fixation Nail System Technique Guide
The Synthes Titanium Trochanteric Fixation Nail (TFN) System
permits an intramedullary approach for the fixation of frac-
tures of the femur. The TFN System consists of a series of
cannulated nails, cannulated helical blades, cannulated
femoral neck screws, cannulated end caps, and locking bolts
and screws. All of the implants in the TFN System are made
of titanium alloy.*
The helical blade provides improved resistance to varus col-
lapse and rotational control of the medial fracture segment
compared to single screw fixation (i.e., lag screws). The result
is superior life-to-cut-out versus single screw fixation. This is
accomplished through the use of the 11.0 mm helical blade.
In addition, the use of the 11.0 mm helical blade results in
reduced bone removal versus use of a traditional hip screw.
These helical blade features are especially advantageous in
osteoporotic fracture fixation. However the TFN system also
offers a lag screw fixation using an 11.0 mm femoral neck
screw.
TFN – Titanium Trochanteric Fixation
Nail System. For intramedullary
fixation of proximal femur fractures.
* Titanium-6% aluminum-7% niobium

110 100 1,000 10,000
1.8 (405 lbs.)
1.6 (360 lbs.)
1.4 (315 lbs.)
1.2 (270 lbs.)
1.0 (225 lbs.)
0.8 (180 lbs.)
0.6 (135 lbs.)
0.4 (90 lbs.)
0.2 (45 lbs.)
0100,000
TFN
Greater resistance to cut-out
The helical blade of the Titanium Trochanteric Fixation Nail
(TFN) System provides increased resistance to cut-out.1
The innovative helical blade design was proven to provide
“superior resistance to migration and subsequent cut-out
failure.”2
Fixation life curves: number of load cycles to cut-out at
varying loads.
When tested at a load of 1.2 kN, the lag screw cut-out
before 1,000 cycles whereas the helical blade cut-out after
10,000 cycles.
Biomechanical Features
1M.B. Sommers, M. Bottlang, C. Roth, H. Hall, .C. Krieg (2004) A laboratory
model to evaluate cutout resistance of implants for pertrochanteric fracture
fixation. ournal of Orthopaedic Trauma, Vol 18(6):361–368
2lbid.
3lbid.
Load [kN (lbs)]
Proximal femur fixation device cut-out3
(Unstable pertrochanteric fracture using simulated cancellous bone)
IM Device
with Lag Screw
Cycles to cut-out
TFN –Titanium Trochanteric Fixation Nail System Technique Guide Synthes 3

1 10 100 1,000 10,000 100,000
25°
20°
15°
10°
5°
0
TFN
TFN
80°
70°
60°
50°
40°
30°
20°
10°
0
1 10 100 1,000 10,000 100,000
4 Synthes TFN – Titanium Trochanteric Fixation Nail System Technique Guide
Biomechanical Features
Improved resistance to varus collapse
4M.B. Sommers, M. Bottlang, C. Roth, H. Hall, .C. Krieg (2004) A laboratory
model to evaluate cutout resistance of implants for pertrochanteric fracture
fixation. ournal of Orthopaedic Trauma, Vol 18(6):361–368
5lbid.
Improved resistance to femoral head rotation
Varus rotation
Cycles
Varus rotation
Varus rotation of femoral head at 1000 N4
(Unstable pertrochanteric fracture using simulated cancellous bone)
Cycles
IM Device
with Lag Screw
IM Device
with Lag Screw
otation of femoral head around implant axis at 1000 N5
(Unstable pertrochanteric fracture using simulated cancellous bone)

1000 10,000 100,000 1,000,000 10,000,000
4.5 (1011 lbs)
4.0 (899 lbs)
3.5 (787 lbs)
3.0 (674 lbs)
2.5 (562 lbs)
2.0 (449 lbs)
1.5 (337 lbs)
1.0 (225 lbs)
0.5 (112 lbs)
0
TFN
6Test conducted at Legacy Research and Technology Center, Portland, OR.
7Test conducted at Synthes Mechanical Testing Lab, West Chester, PA.
The 11.0 mm helical blade reduces amount of bone
removed6
By using the 11.0 mm helical blade, significantly less bone is
removed than with a predrilled lag screw.
The helical blade compacts trabecular bone around the blade
as it advances into the femoral head.
Note: The amount of bone removed by an implant is directly
related to its cross-sectional area. The helical blade’s cross-
sectional area is only 38% that of a standard lag screw.
Longer fatigue life in mechanical testing7
Example of bone removal
with standard lag screw
Example of bone removal
with helical blade
Load [kN (lbs)]
Fatigue life
Cycles
IM Device
with Lag Screw
TFN – Titanium Trochanteric Fixation Nail System Technique Guide Synthes 5

6 Synthes TFN – Titanium Trochanteric Fixation Nail System Technique Guide
In 1958, the AO formulated four basic principles, which have
become the guidelines for internal fixation.8,9 Those prin -
ciples, as applied to the Titanium Trochanteric Fixation Nail
System, are:
Anatomic reduction
The Titanium Trochanteric Fixation Nail allows controlled
dynamic collapse and interfragmentary compression while
maintaining rotational control of the medial segment.
Stable fixation
The Trochanteric Fixation Nail System provides improved re-
sistance to varus collapse and rotational control of the medial
fracture segment versus single screw fixation (i.e., lag screws).
This results in superior life-to-cut-out versus single screw
fixation.
Preservation of blood supply
The instruments and implants in the Trochanteric Fixation
Nail System permit a more percutaneous technique and less
tissue stripping than current treatment methods. An in-
tramedullary approach shows decreased blood loss versus
plate fixation of subtrochanteric fractures.10,11 Use of the
11.0 mm helical blade results in reduced bone removal com-
pared to a hip screw.
Early, active mobilization
The shortened moment arm associated with an intra -
medullary approach permits early mobilization. In conjunc-
tion with AO principles, the Trochanteric Fixation Nail System
creates an environment for bone healing and rapid rehabili-
tation. For stable fractures, early postoperative weightbear-
ing is possible.
AO Principles
8M.E. Müller, M. Allgöwer, R. Schneider, and H. Willenegger (1991), Manual of
Internal Fixation, 3rd Edition. Berlin: Springer
9Rüedi TP, Buckley RE, Moran CG (2007) AO Principles of Fracture Management.
2nd expanded ed. 2002. Stuttgart, New York: Thieme
10 M. Baumgaertner, S. Curtin, D. Lindskog (1998). Intramedullary Versus
Extramedullary Fixation for the Treatment of Intertrochanteric Hip Fractures.
Clinical Orthopaedics and Related Research, 348, 87–94
11 D. Hardy, P. Descamps, P. Krallis, et al (1998). Use of an Intramedullary Hip-Screw
Compared with a Compression Hip-Screw with a Plate for Intertrochanteric
Femoral Fractures. The ournal of Bone and oint Surgery, 80-A(5), 618–630

The Synthes Titanium Trochanteric Fixation Nail (TFN) is in-
tended to treat stable and unstable pertrochanteric fractures,
intertrochanteric fractures, basal neck fractures, and combi-
nations thereof. The Long TFN is additionally indicated for
subtrochanteric fractures, pertrochanteric fractures associ-
ated with shaft fractures, pathologic fractures of osteo-
porotic bone (including prophylactic use) in both trochanteric
and diaphyseal regions, long subtrochanteric fractures, proxi-
mal or distal nonunions, malunions, and revisions.
Indications
Long (300 mm– 460 mm)
Trochanteric Fixation Nails
with helical blade
Short (170 mm and 235 mm)
Trochanteric Fixation Nails
with helical blade
Long (300 mm– 460 mm)
Trochanteric Fixation Nails
with screw
Short (170 mm and 235 mm)
Trochanteric Fixation Nails
with screw
TFN – Titanium Trochanteric Fixation Nail System Technique Guide Synthes 7

Clinical Cases
Case 1
Case 2
8 Synthes TFN – Titanium Trochanteric Fixation Nail System Technique Guide
Preoperative AP Preoperative lateral Postoperative AP Postoperative lateral
Preoperative AP Preoperative lateral Postoperative AP Postoperative lateral

Preoperative Implant Selection
Use the AO preoperative planner rulers for the Titanium
Trochanteric Fixation Nail System to determine nail length,
nail diameter, femoral neck angle and head element length.
The head element should be centered in the AP and lateral
views of the femoral head.
Note: Check the magnification on the specific preoperative
planner ruler. Magnification levels are either 0% or 15%.
Determine the typical magnification factor at your institution
and then adjust measurements accordingly. To do this, divide
the measured length by the magnification factor and choose
the nearest nail length. Note that this will provide an esti-
mated nail length and implant size.
Example (for 0% magnification planner ruler):
– Measured nail length is 420 mm
– Typical femoral x-ray image is enlarged by 5%
(magnification factor 1.05)*
– 420/1.05 = 400
– Estimated nail length is 400 mm
When selecting nail size, consider canal diameter, fracture
pattern, patient anatomy, and postoperative protocol.
* Magnification factor may vary
125°130°
135°
10 mm 11 mm
12mm
170 mm
10 mm 11 mm 12 mm
mm 0
Titanium Helical Blade
80 mm – 120 mm
(5 mm increments)
Lateral View A-P View
80
85
90
95
100
105
110
115
120
END CAP EXTENSIONS
0 mm
5mm
10 mm
170 mm
235 mm 235 mm
mm 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 210 220 230 240
0
Titanium Trochanteric Fixation Nail Ruler
AO
For distal locking use
4.9 mm Titanium Locking Bolts or
5.0 mm Titanium Locking Screws
7/08 GP2026-B J8770A
For use only with the instruments and implants approved by the AO Foundation.
170 mm and 235 mm Lengths, for 10 mm, 11 mm, and 12 mm Cannulated Nails
Millimeters Illustrations shown actual size (0% Magnification)
135º
*14 mm nails only available in 130° neck angle
Titanium Trochanteric Fixation Nail Ruler
AO
300 mm to 460 mm Lengths for 10 mm, 11 mm, 12 mm and 14 mm* Cannulated Nails for Left Femur
300 mm 320 mm 340 mm340 mm 360 mm 380 mm 400 mm 420 mm 440 mm 460 mm
10080604020
mm 0
For distal locking use 4.9 mm Titanium Locking bolts or
5.0 mm Titanium Locking Screws
Right Femur
Lateral View
A-P View
10 mm
5 mm
0 mm
End Cap
Extensions
80mm 0 85 90 95 100 105 110 115 120 125 130
For 300 – 460 mm Titanium
Trochanteric Fixation Nails
Illustrations actual size
(0% Magnification) 75
Titanium Helical Blade
75 mm – 130 mm
(In 5 mm increments)
J3898B GP2025-B 1/08
10mm
11mm12mm14mm*
10mm
11mm12mm
125º
130º*
14mm*
TFN – Titanium Trochanteric Fixation Nail System Technique Guide Synthes 9

(10°–15°)
Affected leg
10 Synthes TFN – Titanium Trochanteric Fixation Nail System Technique Guide
1
Position patient
Position the patient in the lateral decubitus or supine posi-
tion on a fracture or radiolucent table. Position the image
intensifier to enable visualization of the proximal femur
in both the AP and lateral planes.
For unimpeded access to the medullary canal, abduct the
upper part of the body approximately 10 –15° to the
contralateral side (or adduct the affected leg by 10 –15°).
Reduce the fracture. The universal large distractor may be
useful when not using a fracture table.
Open Proximal Femur
2
Determine femoral neck angle
Instruments
357.391 Radiographic Ruler for TFN
357.399 Guide Wire 3.2 mm, length 400 mm
The three oblique slots at the proximal end of the radio -
graphic ruler can be used to determine the femoral neck an-
gle. Select a 3.2 mm guide wire and clamp the guide wire
into one of the grooves marked 125°, 130°, or 135°. Position
the ruler over the proximal femur and take an AP image.
Select the angle that most closely matches the angle of the
femoral neck.

3
Determine nail length
(For nails 300 mm – 460 mm)
Instrument
357.391 Radiographic Ruler for TFN
Position the image intensifier for an AP view of the proximal
femur. With long forceps, clamp the guide wire in the appro-
priate neck angle position as previously determined. Place
the radiographic ruler over the femur. Adjust the radio -
graphic ruler until the guide wire is centered in the femoral
head. Mark the skin at the proximal end of the ruler.
Move the image intensifier to the distal femur, replace the
proximal end of the radiographic ruler at the skin mark and
take an AP image of the distal femur. Verify fracture reduc-
tion. Read nail length directly from the ruler image, selecting
the measurement that places the distal end of the nail at,
or just proximal to, the physeal scar, or the chosen insertion
depth.
Alternative technique
Instrument
360.255 Measuring Device for Reaming Rod for TFN
Nail length may also be determined by using the reaming rod
measuring device and a 950 mm reaming rod or guide rod.
Insert the reaming rod to hold fracture reduction. Position
the image intensifier over the distal femur and take an image
to confirm reaming rod insertion depth. Pass the reaming
rod measuring device over the proximal end of the reaming
rod and through the incision to the bone. Read nail length
directly from the measuring device.
TFN – Titanium Trochanteric Fixation Nail System Technique Guide Synthes 11

12 Synthes TFN – Titanium Trochanteric Fixation Nail System Technique Guide
4
Determine nail diameter
To determine nail diameter, position the image intensifier for
an AP view of the femur at the level of the isthmus. Hold
the radiographic ruler perpendicular to the femur and posi-
tion the diameter tabs over the isthmus. Read the diameter
measurement on the tab that fills the canal.
Note: Take into consideration that the ruler is not at the
same level as the femur. This will affect the accuracy of the
measurement.
Open Proximal Femur

6°
5
Identify nail entry point
Instruments
357.392 Drill Sleeve 17.0/3.2, length 161 mm,
for No. 357.410
357.393 Trocar 3.2 mm, length 172 mm,
for No. 357.392
357.399 Guide Wire 3.2 mm, length 400 mm
357.410 Protection Sleeve 22.0/17.0,
for No. 357.394
393.100 Universal Chuck with T-Handle
The entry point for the nail is in line with the medullary canal
in the lateral view. In the AP view, the nail insertion point
is slightly lateral to the tip of the greater trochanter, in the
curved extension of the medullary cavity.
Make a longitudinal incision proximal to the greater
trochanter. Carry the dissection down to the gluteus max-
imus fascia longitudinally in the direction of the wound.
Separate the underlying muscle fibers and palpate the tip of
the greater trochanter. Insert the 22.0 /17.0 protection sleeve,
the 17.0 / 3.2 drill sleeve, and the 3.2 mm trocar assembly
into the incision site and down to the bone. Remove the
trocar.
The lateral angle of the nail is 6°; therefore, the 3.2 mm
guide wire must be inserted at an angle 6° lateral to the
shaft of the femur, and intersect the centerline of the canal,
just distal to the lesser trochanter. The guide wire will be
centered in the canal in the lateral view. The guide wire can
be inserted either manually with the universal chuck with
T-handle or with a power drill.
Axial and AP view
of insertion site
Guide wire
entry path
Anatomic
axis
TFN – Titanium Trochanteric Fixation Nail System Technique Guide Synthes 13

14 Synthes TFN – Titanium Trochanteric Fixation Nail System Technique Guide
Insert the guide wire through the protection sleeve and drill
sleeve. Confirm guide wire placement in both the AP and
lateral planes. Insert to a depth of approximately 15 cm. Re-
move the drill sleeve.
Open Proximal Femur

6
Open canal
Instruments
351.050 Tissue Protector
357.394 Drill Bit 17.0 mm, cannulated,
length 300 mm,
for Quick Coupling No. 511.760
357.399 Guide Wire 3.2 mm, length 400 mm
357.412 Awl for TFN
Place the 17.0 mm cannulated drill bit into a power drill. Pass
the drill bit over the guide wire and through the protection
sleeve to the bone. Drill to the stop.
Note: If the fracture line runs through the entry point for the
nail, care must be taken to remove the bone on the medial
fragment to create a path for the nail and prepare an ade-
quate opening for the proximal end of the nail. Do not
plunge the drill bit through the fracture as this may displace
the fracture and cause the fracture to be fixed in varus.
When the 17.0 mm drill bit is removed, the 3.2 mm guide
wire may be captured and removed simultaneously. If the
guide wire remains in the bone, remove it by hand.
Dispose of the guide wire. Do not reuse.
Note: The cannulated reverse awl may also be used to open
the canal or expand the opening created by the 17.0 mm
drill bit. Use the tissue protector to spare the soft tissues.
Place the awl over the guide wire and to the bone. Use a
twisting motion to advance the awl. As with the cannulated
drill bit, take care not to plunge the awl into the fracture site
because this may displace the fracture and cause the fracture
to be fixed in varus. Take care to remove the bone on the
medial segment of the fracture to prepare an adequate
opening for the proximal end of the nail.
TFN – Titanium Trochanteric Fixation Nail System Technique Guide Synthes 15

16 Synthes TFN – Titanium Trochanteric Fixation Nail System Technique Guide
7
eaming guidelines (optional)
Instrument
360.255 Measuring Device for Reaming Rod for TFN
Using image intensification, ensure that fracture reduction
has been maintained. Insert the 2.5 mm reaming rod with
olive ball tip into the medullary canal to the desired insertion
depth.
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.
Ream to a diameter at least 1.0 mm greater than the nail
diameter as determined by surgeon preference.
After reaming, remove the reaming assembly, leaving the
reaming rod in place.
Note: The trochanteric fixation nail can be passed over the
2.5 mm reaming rod, with olive ball tip, if used. No reaming
rod exchange is required.
Nail length may be determined by using the reaming rod
measuring device and a 950 mm reaming rod or guide rod.
Insert the reaming rod to hold fracture reduction. Position
the image intensifier over the distal femur and take an image
to confirm reaming rod insertion depth. Pass the reaming
rod measuring device over the proximal end of the reaming
rod and through the incision to the bone. Read nail length
directly from the measuring device.
Open Proximal Femur

1
Assemble insertion instruments
Instruments
357.397 Connecting Screw, cannulated, for TFN
357.411 Insertion Handle for TFN
357.515 Screwdriver, hexagonal,
with spherical head 8.0 mm
357.406 Screwdriver, hexagonal, 5.0 mm, flexible
The sterile nail is packaged with a protective plug in the
proximal end of the nail. Remove and dispose of the plug.
Orient the insertion handle laterally and match the geometry
of the handle to the nail.
Note: For long (300 mm to 460 mm) nails, the bow of the
nail must be aligned with the anterior bow of the femur.
Also confirm left or right nail is being assembled for correct
affected limb.
Pass the cannulated connecting screw through the insertion
handle and into the nail. Secure using the ball hexagonal
screwdriver.
To verify appropriate position of the locking mechanism for
the head element, pass the 5.0 mm flexible hexagonal
screwdriver through the cannulated connecting screw and
turn counterclockwise until it stops.
Important: Ensure that the connecting screw is tight to
avoid misalignment when inserting the head element
through the aiming arm. Do not attach the aiming arm to
the handle until after the nail is fully inserted.
Insert Nail
TFN – Titanium Trochanteric Fixation Nail System Technique Guide Synthes 17

18 Synthes TFN – Titanium Trochanteric Fixation Nail System Technique Guide
2
Insert nail
Instrument
357.411 Insertion Handle for TFN
For short nails (170 mm and 235 mm), orient the insertion
handle laterally, taking into consideration the anteversion of
the femoral head and neck. Manually insert the nail into the
femoral opening. When using a reaming rod, pass the can-
nulated nail over the reaming rod and into the femoral open-
ing.
Optional technique
Ensure correct anteversion of the nail by placing a guide wire
ventral to the femoral neck and into the femoral head.
Under image intensification, verify fracture reduction and
insert the nail as far as possible by hand. Use the insertion
assembly to manipulate the nail across the fracture.
When inserting a short nail, no hammer blows should
be required.
Insert Nail