The Calcaneal Plate. The Synthes non-locking solution for the Calcaneus. Surgical Technique This publication is not intended for distribution in the USA. Instruments and implants approved by the AO Foundation.
Table of Contents Introduction Indications 2 Surgical Technique Implantation 3 Implant Removal 8 Product Information Implants 9 Instruments 10 MRI Information 11 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: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance 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: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance The Calcaneal Plate Surgical Technique DePuy Synthes 1
Indications The calcaneal plates address fractures of the calcaneus. The calcaneal plate is indicated for fractures and osteotomies of the calcaneus including, but not limited to, extra-articular, intra-articular, joint depression and tongue type fractures. 2 DePuy Synthes The Calcaneal Plate Surgical Technique
Implantation 1 Surgical Approach Place the patient in lateral decubitus position. Make an extensile, 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. A no-touch technique may be employed by retracting the flap with Kirschner wires in the talus and in the cuboid, or with an oral surgery tongue retractor. Precaution: Care must be taken to avoid prolonged traction of the flap, especially if Kirschner wires are used. The Calcaneal Plate Surgical Technique DePuy Synthes 3
Implantation 2 Reduce the fracture Reduce fracture fragments. If Kirschner wires are used to temporarily reduce the fracture, they must be placed to avoid interference with final plate placement. To accomplish this, lay a plate on the calcaneus. Note: A Schanz screw and universal chuck with T-handle, or the Synthes small distractor, can be used to aid in the reduction of fracture fragments. 4 DePuy Synthes The Calcaneal Plate Surgical Technique
3 Cut/contour the plate Instruments 391.962 Bending/Cutting Pliers 391.963 Universal Bending Pliers, length 165 mm If necessary, remove a hole of the plate using bending/ cutting pliers. Due to calcaneal soft tissue anatomy, it may be helpful to pre-bend the calcaneal plate prior to plate application. Using the universal bending pliers, contour the plate in fine increments until a desired fit is achieved. Warning: Do not repeatedly bend the plates back and forth as this may weaken the plate. The Calcaneal Plate Surgical Technique DePuy Synthes 5
Implantation 4 Screw placement Instruments 310.210 Drill Bit B 2.0 mm, length 125/100 mm, or 310.190 Drill Bit B 2.0 mm, length 100/75 mm, 310.230 Drill Bit B 2.5 mm, length 180/155 mm, or 310.250 Drill Bit B 2.5 mm, length 110/85 mm, 310.280 Drill Bit B 2.7 mm, length 125/100 mm, 310.350 Drill Bit B 3.5 mm, length 110/85 mm, 2-flute, or Quick Coupling 314.020 Screwdriver, hexagonal, small, with Holding Sleeve 319.010 Depth Gauge for Screws B 2.7 to 4.0 mm, measuring range up to 60 mm 323.260 Universal Drill Guide 2.7 323.360 Universal Drill Guide 3.5 Determine whether 2.7 mm or 3.5 mm cortex screws will be used for fixation. A combination of all two screws may be used. 6 DePuy Synthes The Calcaneal Plate Surgical Technique
A. To secure the plate with 2.7 mm cortex screws, insert the 2.0 mm end of the 2.7 mm universal drill guide into the plate hole and drill through both cortices with a 2.0 mm drill bit. Measure for screw length using the depth gauge. Select and insert an appropriate length 2.7 mm self-tapping cortex screw using the small hexagonal screwdriver. Note: To lag a 2.7 mm screw through a plate hole, use a 2.7 mm drill bit to overdrill the near cortex. Insert the 2.7 mm end of the 2.7 mm universal drill guide into the plate hole and drill through the near cortex with a 2.7 mm drill bit. B. To secure the plate with 3.5 mm cortex screws, insert the 2.5 mm end of the 3.5 mm universal drill guide into a plate hole and drill through both cortices with a 2.5 mm drill bit. Measure for screw length using the depth gauge. Select and insert an appropriate length 3.5 mm self-tapping cortex screw using the Stardrive screwdriver or the small hexagonal screwdriver, whichever is appropriate. Note: To lag a 3.5 mm cortex screw through a plate hole, use a 3.5 mm drill bit to overdrill the near cortex. Insert the 3.5 mm end of the 3.5 mm universal drill guide into the plate hole and drill through the near cortex with a 3.5 mm drill bit. The Calcaneal Plate Surgical Technique DePuy Synthes 7
Implantation 5 Ensure proper reconstruction Precaution: Ensure proper joint reconstruction, screw placement and screw length under image intensification. Verify that the screws are not in the joint or in the soft tissue. 6 Implant Removal In case the physician decides to remove the implants, implants can be removed by using general surgical instruments. In case of difficult removal circumstances, a Screw Extraction Set is available with corresponding instructions (036.000.917). 8 DePuy Synthes The Calcaneal Plate Surgical Technique
Implants Plates X41.610* X41.620* Calcaneal Plate 3.5, length 60 mm Calcaneal Plate 3.5, length 70 mm Screws X02.820 860 Cortex Screw B 2.7 mm, self-tapping, length 20 60 mm X04.810 860 Cortex Screw B 3.5 mm, self-tapping, length 10 60 mm X = 2: Stainless Steel X = 4: Titanium * Available sterile and non-sterile The Calcaneal Plate Surgical Technique DePuy Synthes 9
Instruments 310.190 Drill Bit B 2.0 mm, length 100/75 mm, 310.210 Drill Bit B 2.0 mm, length 125/100 mm, 310.230 Drill Bit B 2.5 mm, length 180/155 mm, 310.250 Drill Bit B 2.5 mm, length 110/85 mm, 310.280 Drill Bit B 2.7 mm, length 125/100 mm, 310.350 Drill Bit B 3.5 mm, length 110/85 mm, 314.020 Screwdriver, hexagonal, small, with Holding Sleeve 319.010 Depth Gauge for Screws B 2.7 to 4.0 mm, measuring range up to 60 mm 323.260 Universal Drill Guide 2.7 323.360 Universal Drill Guide 3.5 391.962 Bending/Cutting Pliers 391.963 Universal Bending Pliers, length 165 mm 11 DePuy Synthes The Calcaneal Plate Surgical Technique
MRI Information Torque, Displacement and Image Artifacts according to ASTM F 2213-06, ASTM F 2052-06e1 and ASTM F2119-07 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 F2182-11a 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. The Calcaneal Plate Surgical Technique DePuy Synthes 11
DSEM/TRM/0815/0488 09/15 Synthes GmbH Eimattstrasse 3 4436 Oberdorf Switzerland Tel: +41 61 965 61 11 Fax: +41 61 965 66 00 www.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 0123 DePuy Synthes Trauma, a division of Synthes GmbH. 2015. All rights reserved. 036.000.944