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SURGICAL TECHNIQUE

Instruments and Implants approved by the AO Foundation.This publication is not intended for distribution in the USA.

VA LOCKING CALCANEAL PLATES 2.7

Image intensifier control

WarningThis description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended.

Processing, Reprocessing, Care and MaintenanceFor 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:http://emea.depuysynthes.com/hcp/reprocessing-care-maintenanceFor 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: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 1

AO PRINCIPLES 2

INTRODUCTION Indications 3

SURGICAL TECHNIQUE VA Locking Calcaneal Plates 2.7 4

Reduction joystick 8

Variable Angle Locking Technique B 2.7 mm 9

Preparation 13

Surgical Technique 15

Implant Removal 24

PRODUCT INFORMATION Implants 25

Screws 26

Instruments 28

Sets 33

MRI INFORMATION 36

TABLE OF CONTENTS

1

4

2

3

4_Priciples_03.pdf 1 05.07.12 12:08

2 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

AO PRINCIPLES

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation.¹, ²

¹ Müller ME, M Allgöwer, R Schneider, H Willenegger. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer. 1991.

² Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme. 2007.

Anatomic reductionFracture reduction and fixation to restore anatomical relationships.

Early, active mobilizationEarly and safe mobilization and rehabilitation of the injured part and the patient as a whole.

Stable fixationFracture fixation providing abso-lute or relative stability, as required by the patient, the injury, and the personality of the fracture.

Preservation of blood supplyPreservation of the blood supply to soft tissues and bone by gentle reduction techniques and careful handling.

Copyright © 2007 by AO Foundation


INDICATIONS

VA Locking Calcaneal Plate 2.7The Synthes Variable Angle Locking Calcaneal plates 2.7 are indicated for intra- and extra-articular fractures of the calcaneus, as well as deformities and malunions.


VA LOCKING CALCANEAL PLATES 2.7

Anatomic, low-profi le plates designed specifi cally for the calcaneus.• Pre-contoured to fi t the anterior

process, posterior facet, and calcaneal tuberosity

Variable Angle Locking screws are de-signed to sit fl ush within the plate* to reduce the likelihood of screw promi-nence creating a low profi le construct when used at nominal angle.

* Variable Angle Locking screws sit fl ush within the platewhen inserted at nominal angle.

** Locking screws inserted only at nominal angle.

Variable Angle Locking Technology Offers a variety of options for fi xation of calcaneal fractures including:• Ability to adapt screw trajectory to

match calcaneal anatomy and fracture pattern

• Ability to angulate screws towards specifi c fragments or areas of cortical bone

Variable Angle Locking screw B 2.7 mm holes:• Accept VA Locking B 2.7 mm,

Metaphyseal, Locking**, and Cortex screws


Variable Angle Locking screw holes target dense cortical bone around the perimeter of the calcaneus when the screws are in-serted at nominal (fi xed) angle.

Tuberosity screws are angled inferior and posterior to target hard cortical bone around the perimeter of the tuberosity.

Variable Angle Locking screws are tar-geted to buttress the posterior and mid-dle facet and converge in the hard bone of the sustentaculum.

Anterior process screws are targeted to buttress the anterior facet and are angled in line with the calcaneal-cuboid joint.• Five screw holes in this area to provide

multiple fi xation options

Strut


Plate profile and screw holes targeting the inferior portion of the tuberosity are located superior to the incision line to reduce the likelihood of the implant causing stress on the incision area.

Strut down the center of the plate is designed to provide additional construct strength and support for any lateral wall comminution.

Plate is designed to allow for additional contouring in the tuberosity and anterior process portion of the plate to improve fit among varying patient anatomy.

Scalloped edge along the posterior facet portion of the plate provides clearance for independent screw fixation. • Scallops accommodate screws size

B 2.7 mm, B 3.5 mm, and B 4.0 mm

VA Locking Calcaneal Plates 2.7


Plate designed with no screw holes in the neutral triangle area of the calcaneus in order to increase plate strength where the fracture line typically lies.

VA Locking Calcaneal Plates 2.7• Available in Small (58 mm), Medium

(64 mm), and Large (70 mm) sizes• Left and right plate designs• Stainless steel and titanium

VA Locking Calcaneal Plates 2.7, with tabsPlates with tabs are available to provide additional support of fracture fragments, especially in the case of severely commi-nuted fractures where screw fixation alone is insufficient or not possible.• Tabs provide additional support of ante-

rior process and plantar fracture frag-ments

• Additional superior screw hole is con-tourable, and allows for supplemental fixation through calcaneal body

• Available in Medium (64 mm) and Large (70 mm) sizes


REDUCTION JOYSTICK

Threaded buttress sleeve

Reduction tool to aid in fracture manipulation.

The threaded buttress sleeve provides a large surface area to reduce the likelihood of cut-out in cancellous bone.

Available in sizes 5.0 mm and 6.5 mm.

Refer to page 16–17 for specific technique information.


1Drill for variable angle locking screwsA. Conical (off nominal-axis) insertion

Instruments

03.211.002 VA LCP Drill Sleeve 2.7, for Drill Bits B2.0 mm

323.062 Drill Bit B 2.0 mm, with double marking, length 140/115 mm, 3-flute, for Quick Coupling

Optional

03.211.003 VA LCP Drill Sleeve 2.7, conical, for Drill Bits B2.0 mm

03.211.200 VA Drill Guide 2.7 with cone point

VARIABLE ANGLE LOCKING TECHNIQUE B 2.7 MM

To insert the Variable Angle Locking screw off the nomi-nal axis, insert the cone-shaped side of drill guide in the desired variable angle locking screw hole in the plate.

The funnel of the drill guide allows a drilling angle within a 30° cone.

When drilling off-axis, the drill guide should remain in place and the drill bit may be aimed in any direction within the cone.

Verify the drill bit angle and depth under radiographic imaging to ensure the desired angle has been achieved.

If necessary, drill at a different angle and verify again under imaging.

Precaution: Avoid excessive re-drilling, especially in poor bone quality.


Variable Angle Locking Technique B 2.7 mm

B. Coaxial (fixed angle) insertion

Instruments


323.062 Drill Bit B 2.0 mm, with double marking, length 140/115 mm, 3-flute, for Quick Coupling

Optional

03.211.004 VA LCP Drill Sleeve 2.7, coaxial, for Drill Bits B2.0 mm

To insert VA locking screws into the plate in line with the predefined screw trajectory insert the coaxial side of the drill sleeve into the desired hole in the plate.

Drill to the desired depth.

Verify the drill bit depth under radiographic imaging.

Use the depth gauge to measure for the correct screw length

Instrument

03.118.007 Depth Gauge, percutaneous

Optional

03.111.005 Depth Gauge for Screws B 2.0 to 2.7 mm, measuring range up to 40 mm

Use the depth gauge to measure for the correct screw length.


2Insert Variable Angle Locking screws

Instrument

314.467 Screwdriver Shaft, Stardrive, T8, self-holding

Optional

03.118.111 Silicone Handle with AO/ASIF Quick Coupling

Insert the correct length Variable Angle Locking screw.

The Variable Angle Locking screws can be inserted manually or with power. For manual insertion, use the Stardrive® Screwdriver Shaft and handle with quick coupling. Initial insertion of Variable Angle Locking screws may be done using power equipment. Do not lock the screws with power tools.

Confirm screw position and length prior to final tighten-ing. Final tightening must be done manually with the torque limiter.

Precautions:• Do not engage the screw head with the plate hole

while inserting under power. Screw engagement and final locking must be done manually with the torque limiter.

• Do not use the torque limiting handle for screw removal.


3Lock Variable Angle Locking screws

Instruments

03.110.002 Torque Limiter, 1.2 Nm, with AO/ASIF Quick Coupling

03.110.005 Handle for Torque Limiters 0.4/0.8/1.2 Nm


Use the torque limiter for final tightening of Variable Angle Locking screws.

The use of the torque limiter is mandatory when engag-ing the screws into Variable Angle Locking holes to en-sure the appropriate amount of torque is applied. Con-firm screw position and length prior to final tightening.

Precaution: Do not lock the screws to the plate un-der power. Screw engagement and final tightening must be done manually with the torque limiter and handle:• 1.2 Nm torque limiter for B 2.7 mm• Do not use the torque limiters for screw removal

Variable Angle Locking Technique B 2.7 mm


Required set(s)

Plates, Stainless steel

01.211.250 VA-Locking Calcaneal Plate 2.7 and VA-Locking Anterolateral Calcaneal Plate 2.7, Stainless Steel, in Modular Tray, Vario Case System

Screws, Stainless steel

01.211.257 Screw Rack Module (metal) for VA Locking Screws 2.7 and Cortex Screws 2.7 (Stainless Steel)

or

Plates, Titanium

01.211.450 VA-Locking Calcaneal Plate 2.7 and VA-Locking Anterolateral Calcaneal Plate 2.7, (Titanium), in Modular Tray, Vario Case System

Screws, Titanium

01.211.258 Screw Rack Module (metal) for VA Locking Screws 2.7 and Cortex Screws 2.7 (Titanium)

Instruments

01.118.226 Instruments for VA-Locking and Cortex Screw Insertion 2.7, in Modular Tray, Vario Case System

01.211.252 Reduction Joystick 5.0 and 6.5 mm, in Modular Tray, Vario Case System

PREPARATION


Optional set(s)

01.111.476 Compression/Distraction Device Set for Orthopaedic Foot Instruments, with Lid, with Contents

01.211.005 Set for Bending Pliers for VA Locking Plates 2.4/2.7

01.211.101 Compression System VA 2.4/2.7, in Modular Tray, Vario Case System

182.669 Special Instrument Set for Hindfoot

Preparation


SURGICAL TECHNIQUE

1Approach

Place the patient in lateral decubitus position. Make an extensile, L-shaped, right-angled lateral incision. The vertical portion of the incision should be just anterior to the heel cord and extend down to the plantar and lateral skin junction. Continue the incision forward, horizon-tally, exposing the calcaneocuboid joint. The incision is carried straight down to bone at its angle and then developed to allow a single, thick flap to be lifted from the periosteal surface.

This approach allows raising a single flap consisting of skin and soft tissue which includes the peroneal tendons, sural nerve and the detached calcaneofibular ligament.

Warning: Care should be taken to avoid the sural nerve when dissecting.


2Reduce fracture

Instruments

292.160 Kirschner Wire B 1.6 mm with trocar tip, length 150 mm, Stainless Steel

492.160 Kirschner Wire B 1.6 mm with trocar tip, length 150 mm, Titanium Alloy (TAV)

or03.211.420– Compression WireB1.6 mm, 03.211.440 length 150 mm, thread length 20–40 mm

Reduce the fracture fragments and hold fragments in place with Kirschner wires. The Kirschner wires should be placed to avoid interference with final plate place-ment.

Optional Technique: Reduction Joystick The Reduction Joystick and Small Universal Chuck with T-handle can be used to aid in the reduction of the tuberosity as required.

Instruments

03.211.454 Reduction Joystick 5.0 mmor 03.211.455 Reduction Joystick 6.5 mm

393.105 Universal Chuck, small, with T-Handle

Assemble the Threaded Buttress Sleeve onto the Reduc-tion Joystick. Thread the Buttress sleeve onto the shaft of the Reduction Joystick to expose all of the bone threads.

Insert the proper size centering pin into the cannulation of the Reduction Joystick. Fully seat the hexagonal head of the Centering Pin into the recess of the Reduction Joystick.

Precaution: The proper size centering pin must be inserted through the cannulation of the Reduction Joystick prior to insertion (Reduction Joystick, 5.0 mm takes 1.6 mm Centering Pin; Reduction Joystick, 6.0 mm takes 2.8 mm Centering Pin).

Bone Threads Threaded Buttress Sleeve

Surgical Technique


Insert the Reduction Joystick under power by connecting to the quick coupling on the centering pin, or manually with the Small Universal Chuck with T-handle.

Remove the centering pin and attach the Small Universal Chuck with T-handle to the Reduction Joystick.

Turn the Threaded buttress sleeve down to the bone so that the surface of the device contacts the bone for added stability.


Pull the tuberosity posterior, inferior, and out of varus.

Optional

01.111.476 Compression/Distraction Device Set for Orthopaedic Foot Instruments, with Lid, with Contents

Use the compression/distraction device to distract the calcaneus and restore length. Place one pin in the cuboid or anterior process and one pin in the tuberosity and distract.

Note: Reference the Orthopaedic Foot Instrument Technique Guide for the Compression Distraction technique steps and product assembly.

Surgical Technique


3Contour plate (optional)

Instrument

03.211.005 Bending Pliers for VA Locking Plates

Plates may require additional contouring depending on patient anatomy. Assess the plate fit and contour further if needed after fracture reduction.

The 2.4 mm/2.7 mm VA LCP Bending Pliers can be used to contour the plate further. The 2.4 mm/2.7 mm VA LCP Bending Pliers should be used to protect the vari-able angle locking screw holes.

Warning: Extensive contouring may weaken the plate.


4Position plate

Instruments

292.160 Kirschner Wire B 1.6 mm with trocar tip, length 150 mm, Stainless Steel

492.160 Kirschner Wire B 1.6 mm with trocar tip, length 150 mm, Titanium Alloy (TAV)

or03.211.420– Compression WireB1.6 mm, 03.211.440 length 150 mm, thread length 20–40 mm

Position plate and provisionally fix the plate to bone with Kirschner wires or 1.6 mm Compression Wires. The plate should sit just under the ridge of the subchondral bone located below the subtalar joint.

Note: If enlarged peroneal tubercle prevents ideal plate placement, the tubercle may need to be removed.

Surgical Technique


Universal Bending Pliers

Locking Calcaneal Plate Tab Bending Pliers

Optional Technique: VA Locking Calcaneal Plate 2.7 with tabs

Instrument


Optional

329.155 Bender for Tabs of Calcaneal Locking Plate

391.963 Universal Bending Pliers, length 165 mm

If using the VA Locking Calcaneal Plate with tabs, use the 2.4/2.7 VA LCP Bending Pliers to contour the superior screw hole.

Use the 2.4/2.7 VA LCP Bending pliers to pre-bend the tabs, while simultaneously protecting the Variable Angle Locking screw hole with a second 2.4/2.7 VA LCP Bend-ing Plier.

OptionalOnce the plate is positioned on the calcaneus, the Locking Calcaneal Plate Tab Bending Pliers may be used to bend the tabs further if needed.

Insert the square portion of the Tab Bending Pliers into the hole adjacent to the tab, and bend the tab.

2.4 mm/2.7 mm VA LCP Bending Pliers


5 Insert screws

For final fixation, insert the Variable Angle Locking screws B 2.7 mm as described in the Variable Angle Locking Technique on page 9–12.

Precautions:• A minimum of four Variable Angle Locking or

Locking screws should be inserted in the posterior facet portion of the plate to provide adequate fixation.*

• Only screws B 2.7 mm should be inserted in the calcaneal plates.

• Use caution when inserting screws targeting the sustentaculum.

Confirm screw positioning under fluoroscopic imaging.

Optional Technique

Metaphyseal screws B 2.7 mm can also be inserted prior to Variable Angle locking screws to ensure appropriate bone contact with the plate.

The Metaphyseal screws B 2.7 mm can be inserted under power or manually following the 2.7 mm Variable Angle Locking Technique on page 9–12.

Precaution: Final metaphyseal screw insertion, similar to a cortex screw, should be completed manually using the T8 Stardrive screwdriver shaft and handle with quick coupling.

* Testing on file at DePuy Synthes.

Surgical Technique


6Lock Variable Angle Locking screws

Lock the Variable Angle Locking screws B 2.7 mm manually with the 1.2 Nm Torque Limiting Attachment and handle as described in the Variable Angle Locking Technique on page 9–12.

Confirm reduction and fixation under fluoroscopic imaging. Take lateral, axial heel, and Broden’s view images.


Instruments



Optional

03.111.038 Handle with Quick Coupling

If implant removal is desired, unlock all screws manually from the plate using the proper screwdriver shaft and handle. Then remove the screws completely from the bone.

Precaution: Do not use the torque limiters for screw removal.

IMPLANT REMOVAL


Right

Right

Left

Left

IMPLANTS

VA Locking Calcaneal Plates 2.7*

Stainless Steel Titanium Right/Left Size Length (mm)

02.211.400 04.211.400 Right Small 58

02.211.401 04.211.401 Left Small 58

02.211.402 04.211.402 Right Medium 64

02.211.403 04.211.403 Left Medium 64

02.211.404 04.211.404 Right Large 70

02.211.405 04.211.405 Left Large 70

* Available nonsterile or sterile-packed. Add “S” to catalog number to order sterile product.

VA Locking Calcaneal Plates 2.7, with tabs*

Stainless Steel Titanium Right/Left Size Length (mm)

02.211.406 04.211.406 Right Medium 64

02.211.407 04.211.407 Left Medium 64

02.211.408 04.211.408 Right Large 70

02.211.409 04.211.409 Left Large 70


SCREWS

The VA Locking Calcaneal plates 2.7 accept the following screws:

Variable Angle Locking Screws B 2.7 mm• Threaded, rounded head locks securely into

the variable angle locking holes• Locked screws allow unicortical screw fixation and

load transfer to near cortex• Used with drill bit B 2.0 mm• T8 Stardrive recess• Self-tapping tip• Color coded for easier identification• Screws in set: 16 mm to 56 mm lengths

(0X.211.016–0X.211.056)• Additionally available: 8 mm to 60 mm lengths

(0X.211.008–0X.211.060)

Note: VA locking screws B 2.7 mm must be tightened to 1.2 Nm.

Metaphyseal Screws B 2.7 mm• For use in locking, non-locking, or combi-holes • Used to provide compression of plate to the bone• Feature locking screw thread in screw shaft• Low-profile head• Used with drill bit B 2.0 mm• T8 Stardrive recess• Self-tapping tip• Screws in set: 16 mm to 56 mm lengths

(0X.118.516–0X.118.556)• Additionally available: 10 mm to 70 mm lengths

(0X.118.510–0X.118.570)

X = 2 (Stainless Steel), 4 (Titanium)


* Also available. X = 2 (Stainless Steel), 4 (Titanium)

Cortex Screws* B 2.7 mm• For use in locking, non-locking, or combi-holes • Used to provide compression or neutral fixation • Used with drill bit B 2.0 mm• T8 Stardrive recess• Self-tapping tip• Additionally available: 10 mm to 60 mm

(X02.870–X02.969)

Locking Screws* B 2.7 mm• Threaded, conical head locks securely into the variable

angle locking holes• Only for axial insertion in the variable angle locking

holes• Used with drill bit B 2.0 mm• T8 Stardrive recess• Self-tapping tip• Additionally available: 8 mm to 60 mm

(X02.208–X02.260)


INSTRUMENTS

323.062 Drill Bit B 2.0 mm, with double marking, length 140/115 mm, 3-fl ute, for Quick Coupling

315.280 Drill Bit B2.7 mm, length 125/100 mm, 3-fl ute, for Quick Coupling


03.110.002 Torque Limiter, 1.2 Nm, with AO/ASIF Quick Coupling

03.110.005 Handle for Torque Limiters 0.4/0.8/1.2 Nm

Also Available

03.211.003 VA LCP Drill Sleeve 2.7, conical, for Drill Bits B2.0 mm

03.211.004 VA LCP Drill Sleeve 2.7, coaxial, for Drill Bits B2.0 mm



323.260 Universal Drill Guide 2.7

313.353 Drill Sleeve 2.7, for Aiming Arm No. 313.354, for DHP

03.211.001 Holding Pin for VA Locking Plates 2.4/2.7


03.118.008 Compression/Distraction Rod for VA Locking Hole B2.7 mm

03.118.007 Depth Gauge, percutaneous


Optional

03.211.200 VA Drill Guide 2.7 with cone point

03.111.005 Depth Gauge for Screws B 2.0 to 2.7 mm, measuring range up to 40 mm

03.211.400 Compression Forceps for use with Compression Wire

Compression Wire B 1.6 mm, length 150 mm, thread Length (mm)

03.211.415 1503.211.420 2003.211.425 2503.211.430 3003.211.435 3503.211.440 40

Kirschner Wire B 1.6 mm with trocar tip, length 150 mm

292.160 Stainless Steel492.160 Titanium Alloy (TAV)

Instruments


Bending Pliers and Reduction Instruments

Reduction Joystick03.211.454 5.0 mm03.211.455 6.5 mm

393.105 Universal Chuck, small, with T-Handle

Optional


391.963 Universal Bending Pliers, length 165 mm

Also Available

329.155 Bender for Tabs of Calcaneal Locking Plate

391.940 Wire Cutter, long, length 230 mm

Centering Pin for Reduction Joystick 03.211.431 B 1.6 mm for B 5.0 mmor03.211.432 B 2.8 mm for B 6.5 mm


310.229 Drill Bit B2.9 mm, length 150 mm, 2-flute, for Quick Coupling

310.401 Drill Bit B4.0 mm, length 160 mm, 2-flute, for Quick Coupling

312.401 Double Drill Guide 4.0/2.9

314.030 Screwdriver Shaft, hexagonal, small, B2.5 mm

Instruments


SETS

01.211.250 VA-Locking Calcaneal Plate 2.7 and VA-Locking Anterolateral Calcaneal Plate 2.7, Stainless Steel, in Modular Tray, Vario Case System

01.211.450 VA-Locking Calcaneal Plate 2.7 and VA-Locking Anterolateral Calcaneal Plate 2.7, (Titanium), in Modular Tray, Vario Case System

Contents:• Modular tray for VA Locking Calcaneal

Plates 2.7 (68.211.250)• One plate per size small, medium and

large, with and without tabs, left and right

The lid for this tray can be ordered separately (68.001.104)

01.211.252 Reduction Joystick 5.0 and 6.5 mm, in Modular Tray, Vario Case System

Contents:• Modular Tray for Reduction Joystick

5.0/6.5 mm (68.211.252)• Reduction Joystick 5.0 mm with

Centering Pin 1.6 mm and sleeve• Reduction Joystick 6.5 mm with

Centering Pin 2.8 mm and sleeve• Universal Chuck, small, with T-Handle



01.118.226 Instruments for VA-Locking and Cortex Screw Insertion 2.7, in Modular Tray, Vario Case System Contents:• Modular tray for VA Locking and Cor-

tex Screw Insertion 2.7 (68.118.006)• Instruments needed for the insertion

of VA Locking and Cortex Screws B 2.7 mm


01.211.005 Set for Bending Pliers for VA Locking Plates 2.4/2.7 Contents:• Modular Tray for Bending Pliers for

VA Locking Plates 2.4/2.7• Bending Pliers for VA Locking Plates

2.4/2.7

Sets


01.211.257 Screw Rack Module (metal) for VA Locking Screws 2.7 and Cortex Screws 2.7 (Stainless Steel)

Contents:• Screw Rack, metal, size 1/2,

(68.118.009), including lid• VA Locking Screw Stardrive

B 2.7 mm, length 10–60 mm • Cortex Screw Stardrive B 2.7 mm,

length 10–60 mm

Optional: • Cortex Screw B 3.5 mm, length

10–50 mm can be ordered if supple-mental fi xation is done with 3.5 mm screws

• Cortex Screw B 4.0 mm, length 20–60 mm can be ordered if supple-mental fi xation is done with screws B 4.0 mm

01.211.258 Screw Rack Module (metal) for VA Locking Screws 2.7 and Cortex Screws 2.7 (Titanium)

Contents:• Screw Rack, metal, size 1/2,

(68.118.009), including lid• VA Locking Screw Stardrive

B 2.7 mm, length 10–60 mm • Cortex Screw Stardrive B 2.7 mm,

length 10–60 mm

Optional: • Cortex Screw B 3.5 mm, length

10–50 mm can be ordered if supple-mental fi xation is done with screws B 3.5 mm

• Cortex Screw B 4.0 mm, length 20–60 mm can be ordered if supple-mental fi xation is done with screws B 4.0 mm


MRI INFORMATION

Torque, Displacement and Image Artifacts according to ASTM F 2213-06, ASTM F 2052-06e1 and ASTM F2119-07Non-clinical testing of worst case scenario in a 3 T MRI system did not reveal any relevant torque or displacement of the construct for an experimentally measured local spatial gradient of the magnetic field of 3.69 T/m. The largest image artifact extended approximately 169 mm from the construct when scanned using the Gradient Echo (GE). Testing was conducted on a 3 T MRI system.

Radio-Frequency-(RF-)induced heating according to ASTM F2182-11aNon-clinical electromagnetic and thermal testing of worst case scenario lead to peak temperature rise of 9.5 °C with an average temperature rise of 6.6 °C (1.5 T) and a peak temperature rise of 5.9 °C (3 T) under MRI Conditions using RF Coils [whole body averaged specific absorption rate (SAR) of 2 W/kg for 6 minutes (1.5 T) and for 15 minutes (3 T)].

Precautions: The above mentioned test relies on non-clinical testing. The actual temperature rise in the patient will depend on a variety of factors beyond the SAR and time of RF application. Thus, it is recommended to pay particular attention to the following points: • It is recommended to thoroughly monitor patients

undergoing MR scanning for perceived tempera-ture and/or pain sensations.

• Patients with impaired thermo regulation or temperature sensation should be excluded from MR scanning procedures.

• Generally it is recommended to use a MR system with low field strength in the presence of conduc-tive implants. The employed specific absorption rate (SAR) should be reduced as far as possible.

• Using the ventilation system may further contrib-ute to reduce temperature increase in the body.

0123

Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com

This publication is not intended for distribution in the USA.

All surgical techniques are available as PDF files at www.depuysynthes.com/ifu ©

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