VA LOCKING CALCANEAL PLATES 2.7

Transcription

1 VA LOCKING CALCANEAL PLATES 2.7 Instruments and Implants approved by the AO Foundation. This publication is not intended for distribution in the USA. SURGICAL TECHNIQUE

2 Image intensifier control Warning This 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 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: 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:

3 TABLE OF CONTENTS AO PRINCIPLES 2 INTRODUCTION Indications 3 SURGICAL TECHNIQUE VA Locking Calcaneal Plates 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 VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 1

4 AO PRINCIPLES In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation.¹, ² 4_Priciples_03.pdf :08 Anatomic reduction Fracture reduction and fixation to restore anatomical relationships. 1 2 Stable fixation Fracture fixation providing absolute or relative stability, as required by the patient, the injury, and the personality of the fracture. Early, active mobilization Early and safe mobilization and rehabilitation of the injured part and the patient as a whole. 4 3 Preservation of blood supply Preservation of the blood supply to soft tissues and bone by gentle reduction techniques and careful handling. Copyright 2007 by AO Foundation ¹ Müller ME, M Allgöwer, R Schneider, H Willenegger. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer ² Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

5 INDICATIONS VA Locking Calcaneal Plate 2.7 The 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 Surgical Technique DePuy Synthes 3

6 VA LOCKING CALCANEAL PLATES 2.7 Anatomic, low-profile plates designed specifically for the calcaneus. Pre-contoured to fit the anterior process, posterior facet, and calcaneal tuberosity Variable Angle Locking screws are designed to sit flush within the plate* to reduce the likelihood of screw prominence creating a low profile construct when used at nominal angle. Variable Angle Locking Technology Offers a variety of options for fixation of calcaneal fractures including: Ability to adapt screw trajectory to match calcaneal anatomy and fracture pattern Ability to angulate screws towards specific 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 screws sit flush within the plate when inserted at nominal angle. ** Locking screws inserted only at nominal angle. 1 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

7 Variable Angle Locking screw holes target dense cortical bone around the perimeter of the calcaneus when the screws are inserted at nominal (fixed) angle. Variable Angle Locking screws are targeted to buttress the posterior and middle 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 fixation options Tuberosity screws are angled inferior and posterior to target hard cortical bone around the perimeter of the tuberosity. VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 1

8 VA Locking Calcaneal Plates 2.7 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 6 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

9 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 tabs Plates with tabs are available to provide additional support of fracture fragments, especially in the case of severely comminuted fractures where screw fixation alone is insufficient or not possible. Tabs provide additional support of anterior process and plantar fracture fragments Additional superior screw hole is contourable, and allows for supplemental fixation through calcaneal body Available in Medium (64 mm) and Large (70 mm) sizes VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 7

10 REDUCTION JOYSTICK 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 for specific technique information. Threaded buttress sleeve 8 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

11 VARIABLE ANGLE LOCKING TECHNIQUE B 2.7 MM 1 Drill for variable angle locking screws A. Conical (off nominal-axis) insertion Instruments VA LCP Drill Sleeve 2.7, for Drill Bits B 2.0 mm Drill Bit B 2.0 mm, with double marking, length 140/115 mm, 3-flute, for Quick Coupling Optional VA LCP Drill Sleeve 2.7, conical, for Drill Bits B 2.0 mm VA Drill Guide 2.7 with cone point To insert the Variable Angle Locking screw off the nominal 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. VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 9

12 Variable Angle Locking Technique B 2.7 mm B. Coaxial (fixed angle) insertion Instruments VA LCP Drill Sleeve 2.7, for Drill Bits B 2.0 mm Drill Bit B 2.0 mm, with double marking, length 140/115 mm, 3-flute, for Quick Coupling Optional VA LCP Drill Sleeve 2.7, coaxial, for Drill Bits B 2.0 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 Depth Gauge, percutaneous Optional 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. 11 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

13 2 Insert Variable Angle Locking screws Instrument Screwdriver Shaft, Stardrive, T8, self-holding Optional 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 tightening. 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. VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 11

14 Variable Angle Locking Technique B 2.7 mm 3 Lock Variable Angle Locking screws Instruments Torque Limiter, 1.2 Nm, with AO/ASIF Quick Coupling Handle for Torque Limiters 0.4/0.8/1.2 Nm Screwdriver Shaft, Stardrive, T8, self-holding Use the torque limiter for final tightening of Variable Angle Locking screws. The use of the torque limiter is mandatory when engaging the screws into Variable Angle Locking holes to ensure the appropriate amount of torque is applied. Confirm screw position and length prior to final tightening. Precaution: Do not lock the screws to the plate under 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 11 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

15 PREPARATION Required set(s) Plates, Stainless steel 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 Screw Rack Module (metal) for VA Locking Screws 2.7 and Cortex Screws 2.7 (Stainless Steel) or Plates, Titanium VA-Locking Calcaneal Plate 2.7 and VA-Locking Anterolateral Calcaneal Plate 2.7, (Titanium), in Modular Tray, Vario Case System Screws, Titanium Screw Rack Module (metal) for VA Locking Screws 2.7 and Cortex Screws 2.7 (Titanium) Instruments Instruments for VA-Locking and Cortex Screw Insertion 2.7, in Modular Tray, Vario Case System Reduction Joystick 5.0 and 6.5 mm, in Modular Tray, Vario Case System VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 11

16 Preparation Optional set(s) Compression/Distraction Device Set for Orthopaedic Foot Instruments, with Lid, with Contents Set for Bending Pliers for VA Locking Plates 2.4/ Compression System VA 2.4/2.7, in Modular Tray, Vario Case System Special Instrument Set for Hindfoot 11 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

17 SURGICAL TECHNIQUE 1 Approach 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, horizontally, 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. VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 11

18 Surgical Technique 2 Reduce fracture Instruments Kirschner Wire B 1.6 mm with trocar tip, length 150 mm, Stainless Steel Kirschner Wire B 1.6 mm with trocar tip, length 150 mm, Titanium Alloy (TAV) or Compression Wire B 1.6 mm, length 150 mm, thread length 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 placement. 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 Reduction Joystick 5.0 mm or Reduction Joystick 6.5 mm Universal Chuck, small, with T-Handle Assemble the Threaded Buttress Sleeve onto the Reduction 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 11 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

19 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. VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 11

20 Surgical Technique Pull the tuberosity posterior, inferior, and out of varus. Optional 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. 11 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

21 3 Contour plate (optional) Instrument 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 variable angle locking screw holes. Warning: Extensive contouring may weaken the plate. VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 11

22 Surgical Technique 4 Position plate Instruments Kirschner Wire B 1.6 mm with trocar tip, length 150 mm, Stainless Steel Kirschner Wire B 1.6 mm with trocar tip, length 150 mm, Titanium Alloy (TAV) or Compression Wire B 1.6 mm, length 150 mm, thread length 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. 22 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

23 Optional Technique: VA Locking Calcaneal Plate 2.7 with tabs Instrument Bending Pliers for VA Locking Plates Optional Bender for Tabs of Calcaneal Locking Plate 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. 2.4 mm/2.7 mm VA LCP Bending Pliers 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 Bending Plier. Universal Bending Pliers Optional Once the plate is positioned on the calcaneus, the Locking Calcaneal Plate Tab Bending Pliers may be used to bend the tabs further if needed. Locking Calcaneal Plate Tab Bending Pliers Insert the square portion of the Tab Bending Pliers into the hole adjacent to the tab, and bend the tab. VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 22

24 Surgical Technique 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 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 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. 22 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

25 6 Lock 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 Confirm reduction and fixation under fluoroscopic imaging. Take lateral, axial heel, and Broden s view images. VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 22

26 IMPLANT REMOVAL Instruments Screwdriver Shaft, Stardrive, T8, self-holding Silicone Handle with AO/ASIF Quick Coupling Optional 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. 22 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

27 IMPLANTS VA Locking Calcaneal Plates 2.7* Stainless Steel Titanium Right/Left Size Length (mm) Right Small Left Small Right Medium Left Medium Right Large Left Large 70 Right Left VA Locking Calcaneal Plates 2.7, with tabs* Stainless Steel Titanium Right/Left Size Length (mm) Right Medium Left Medium Right Large Left Large 70 Right Left * Available nonsterile or sterile-packed. Add S to catalog number to order sterile product. VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 22

28 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 X ) Additionally available: 8 mm to 60 mm lengths (0X X ) 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 X ) Additionally available: 10 mm to 70 mm lengths (0X X ) X = 2 (Stainless Steel), 4 (Titanium) 22 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

29 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 (X 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 (X X02.260) * Also available. X = 2 (Stainless Steel), 4 (Titanium) VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 22

30 INSTRUMENTS Drill Bit B 2.0 mm, with double marking, length 140/115 mm, 3-flute, for Quick Coupling Drill Bit B 2.7 mm, length 125/100 mm, 3-flute, for Quick Coupling VA LCP Drill Sleeve 2.7, for Drill Bits B 2.0 mm Torque Limiter, 1.2 Nm, with AO/ASIF Quick Coupling Handle for Torque Limiters 0.4/0.8/1.2 Nm Also Available VA LCP Drill Sleeve 2.7, conical, for Drill Bits B 2.0 mm VA LCP Drill Sleeve 2.7, coaxial, for Drill Bits B 2.0 mm 28 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

31 Depth Gauge, percutaneous Screwdriver Shaft, Stardrive, T8, self-holding Universal Drill Guide Drill Sleeve 2.7, for Aiming Arm No , for DHP Holding Pin for VA Locking Plates 2.4/ Silicone Handle with AO/ASIF Quick Coupling Compression/Distraction Rod for VA Locking Hole B 2.7 mm VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 29

32 Instruments Optional VA Drill Guide 2.7 with cone point Depth Gauge for Screws B 2.0 to 2.7 mm, measuring range up to 40 mm Compression Forceps for use with Compression Wire Compression Wire B 1.6 mm, length 150 mm, thread Length (mm) Kirschner Wire B 1.6 mm with trocar tip, length 150 mm Stainless Steel Titanium Alloy (TAV) 31 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

33 Bending Pliers and Reduction Instruments Reduction Joystick mm mm Universal Chuck, small, with T-Handle Optional Bending Pliers for VA Locking Plates Universal Bending Pliers, length 165 mm Also Available Bender for Tabs of Calcaneal Locking Plate Wire Cutter, long, length 230 mm Centering Pin for Reduction Joystick B 1.6 mm for B 5.0 mm or B 2.8 mm for B 6.5 mm VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 33

34 Instruments Drill Bit B 2.9 mm, length 150 mm, 2-flute, for Quick Coupling Drill Bit B 4.0 mm, length 160 mm, 2-flute, for Quick Coupling Double Drill Guide 4.0/ Screwdriver Shaft, hexagonal, small, B 2.5 mm 33 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

35 SETS VA-Locking Calcaneal Plate 2.7 and VA-Locking Anterolateral Calcaneal Plate 2.7, Stainless Steel, in Modular Tray, Vario Case System 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 ( ) One plate per size small, medium and large, with and without tabs, left and right The lid for this tray can be ordered separately ( ) 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 ( ) 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 The lid for this tray can be ordered separately ( ) VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 33

36 Sets Instruments for VA-Locking and Cortex Screw Insertion 2.7, in Modular Tray, Vario Case System Contents: Modular tray for VA Locking and Cortex Screw Insertion 2.7 ( ) Instruments needed for the insertion of VA Locking and Cortex Screws B 2.7 mm The lid for this tray can be ordered separately ( ) 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/ DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

37 Screw Rack Module (metal) for VA Locking Screws 2.7 and Cortex Screws 2.7 (Stainless Steel) Contents: Screw Rack, metal, size 1/2, ( ), including lid VA Locking Screw Stardrive B 2.7 mm, length mm Cortex Screw Stardrive B 2.7 mm, length mm Optional: Cortex Screw B 3.5 mm, length mm can be ordered if supplemental fixation is done with 3.5 mm screws Cortex Screw B 4.0 mm, length mm can be ordered if supplemental fixation is done with screws B 4.0 mm Screw Rack Module (metal) for VA Locking Screws 2.7 and Cortex Screws 2.7 (Titanium) Contents: Screw Rack, metal, size 1/2, ( ), including lid VA Locking Screw Stardrive B 2.7 mm, length mm Cortex Screw Stardrive B 2.7 mm, length mm Optional: Cortex Screw B 3.5 mm, length mm can be ordered if supplemental fixation is done with screws B 3.5 mm Cortex Screw B 4.0 mm, length mm can be ordered if supplemental fixation is done with screws B 4.0 mm VA Locking Calcaneal Plates 2.7 Surgical Technique DePuy Synthes 31

38 MRI INFORMATION Torque, Displacement and Image Artifacts according to ASTM F , ASTM F e1 and ASTM F Non-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 F a Non-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 temperature 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 conductive implants. The employed specific absorption rate (SAR) should be reduced as far as possible. Using the ventilation system may further contribute to reduce temperature increase in the body. 33 DePuy Synthes VA Locking Calcaneal Plates 2.7 Surgical Technique

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42 Synthes GmbH Eimattstrasse Oberdorf Switzerland Tel: Fax: This publication is not intended for distribution in the USA. All surgical techniques are available as PDF files at DePuy Synthes Trauma, a division of Synthes GmbH All rights reserved. DSEM/TRM/0415/0362(1) 09/15