OPERATIVE TECHNIQUE RIVAL REDUCE FRACTURE PLATING SYSTEM. foot & ankle trauma procedures

Transcription

1 OPERATIVE TECHNIQUE RIVAL REDUCE FRACTURE PLATING SYSTEM foot & ankle trauma procedures

2 INTRODUCTION 3 SYSTEM DESCRIPTION 3 TECHNICAL DETAILS 4 SALES AND MARKETING CONFIGURATION 5 OPERATIVE TECHNIQUE 7

3 OPERATIVE TECHNIQUE 3 INTRODUCTION This operative technique explains the recommended procedures for using the RIVAL REDUCE Fracture Plating System s devices and instruments. Please refer to the corresponding instructions below on specific steps. The IFU (Instruction For Use) leaflet contains the indications for use as well as the contraindications and has been included in the packaging of all implants. It can also be found at SYSTEM DESCRIPTION The RIVAL REDUCE Fracture Plating System includes titanium alloy, sterile packaged T, L, Y, Straight plates, H Plates and BOX plates along with sterile titanium alloy bone screws. The RIVAL REDUCE Fracture Plating System is offered in a variety of sizes for use with the RIVAL non-locking and locking bone screws. The screws are available in variety of diameters and lengths The corresponding instrumentation necessary for insertion is found in Orthofix s RIVAL Instrumentation.

4 4 OPERATIVE TECHNIQUE TECHNICAL DETAILS Table 1: RIVAL REDUCE Fracture Plating System PLATES Straight T-Plate Y-Plate L-Plate H-Plate BOX Plate Plate Thickness 1.3mm 1.3mm 1.3mm 1.3mm 1.3mm 1.3mm Plate Sizes 3, 4 and 6 Hole Small and Large Small and Large Left and Right 12mm, 15mm, 17mm, 20mm, 22mm, 25mmand 30mm 18mm, 20mm, 22mm, 25mm and 30mm Anodization Gun Metal Gray Gun Metal Gray Gun Metal Gray Gun Metal Gray Gun Metal Gray Gun Metal Gray BONE SCREWS 2.0mm Locking 2.0mm Non- Locking 2.7mm Locking 2.7mm Non-Locking Size Range 8 to 40mm 9 to 40mm 10 to 40mm 11 to 40mm Length Increments 2mm 2mm 2mm 2mm Drill Size 1.5mm 1.5mm 2mm 2mm Anodization Vector Purple Vector Purple Gun Metal Gray Gun Metal Gray RIVAL Instrument Set - Top Tray Part# Description Q.ty 001-A Parallel Wire Guide, 4.0/4.5mm Screw A Paralle Wire Guide, 6.5/8.0mm Screws A Small Depth Gauge, 0.9mm, 1.1mm and 1.5mm Guide 1 Wires 001-A Large Depth Gauge, 2.8mm Guide Wire A Small Ratcheting Handle, Cannulated, A Medium Ratcheting Handle, Cannulated, A Large Ratcheting Handle, Cannulated, A Cannulated Cruciform Driver, 2.0/2.5mm Headed Screw, A Cannulated Cruciform Driver, 3.0/3.5mm Headed Screw, A Cannulated Cruciform Driver, 4.0/4.5mm Headed Screw, A Cannulated Cruciform Driver, 6.5/8.0mm Headed Screw, A Cannulated Hex Driver, 2.0/2.5mm Headless Screw, A Cannulated Hex Driver, 3.0/3.5mm Headless Screw, A Cannulated Hex Driver, 4.0/4.5mm Headless Screw, A Cannulated Hex Driver, 6.5/7.5mm Headless Screw, A Pin Inserter, 0.9mm and 1.1mm Guide Wire A Pin Inserter, 1.5mm Guide Wire A Hex Screw Driver, For 2.0/2.7/3.2mm Screws, Quick 2 Connect 002-A Drill Guide (Locking And Non-Locking) A Depth Gauge With Hook A Locking Drill Sleeve 2 RIVAL Instrument Set - Middle Tray Part# Description Q.ty 001-A Small Joint Distraction Forceps, 1.5mm Guide Wire A Joint Compression Forceps A Bone Reduction Forceps, A Bone Reduction Forceps, A Plate Bending Iron, Left A Plate Bending Iron, Right A Plate Bending Joistick A Cup Reamer, 14mm, A Cup Reamer, 16mm, A Cup Reamer, 18mm, A Cup Reamer, 20mm, A Cone Reamer, 14mm, A Cone Reamer, 16mm, A Cone Reamer, 18mm, A Cone Reamer, 20mm, A Soft Tissue Elevator A Lobster Claw 1

5 OPERATIVE TECHNIQUE 5 RIVAL Instrument Set - REDUCE Trial Caddy Part# Description Q.ty 003-A Reduce Trial, T-Plate, Small A Reduce Trial, T-Plate, Large A Reduce Trial, Y-Plate, Small A Reduce Trial, Y-Plate, Large A Reduce Trial, Straight Plate, 3 Hole A Reduce Trial, Straight Plate, 4 Hole A Reduce Trial, Straight Plate, 6 Hole A-00006L Reduce Trial, L-Plate, Left A-00006R Reduce Trial, L-Plate, Right A Reduce Trial, Box Plate, 18mm A Reduce Trial, Box Plate, 20mm A Reduce Trial, Box Plate, 22mm A Reduce Trial, Box Plate, 25mm A Reduce Trial, Box Plate, 30mm A Reduce Trial, H-Plate, 12mm A Reduce Trial, H-Plate, 15mm A Reduce Trial, H-Plate, 17mm A Reduce Trial, H-Plate, 20mm A Reduce Trial, H-Plate, 22mm A Reduce Trial, H-Plate, 25mm A Reduce Trial, H-Plate, 30mm 1 REDUCE Fracture Plates are designed to be used with 2.0mm and 2.7mm locking and non-locking screws (*). The locking screws lock flush into the plates reducing screw prominence. The REDUCE Fracture Plates include an oblong compression hole for intraoperative compression capabilities up to 1.1mm with the corresponding non-locking screws. The REDUCE Fracture Plates are designed with guide wire holes for easy implant placement during surgery. SALES AND MARKETING CONFIGURATION RIVAL REDUCE Fracture Plating System Configurations Implant Range 000-K-011 RIVAL REDUCE KIT SCREWS Locking and non-locking, 2.0 and 2.7mm plating screws 000-K-012 RIVAL REDUCE KIT PLATES T, Y, Straight, L, BOX and H Plates

6 6 OPERATIVE TECHNIQUE Examples of RIVAL REDUCE Plates applications

7 OPERATIVE TECHNIQUE 7 OPERATIVE TECHNIQUE Preoperative Planning The RIVAL REDUCE Fracture Plating System is composed of a variety of plates and bone screws. Detailed preoperative planning is important for determining appropriate screw and plate size and location for the desired procedure(s) being performed. Surgical Technique The operative technique listed below is designed to provide general principles for the use of the RIVAL REDUCE Fracture Plating System. Implantation Site Exposure Expose the implantation site with the appropriate surgical approach specific to the procedure(s) being performed. The surgical approach should facilitate adequate visualization of important anatomic structures and facilitate use of instrumentation and implant placement. Plate Selection INSTRUMENTS Part# Description BONE REDUCTION FORCEPS (optional) 001-A Bone Reduction Forceps, 8inch 001-A Bone Reduction Forceps, 10inch Reduce and provisionally fix the fracture/osteotomy site with K-wires or bone reduction forceps. Use the RIVAL REDUCE plate trials found in the RIVAL Instrumentation to confirm plate type and size that best achieves the goals of fixation (see Table 1 page 4) (Fig. 1). REDUCE PLATE TRIALS 003-A-00006L Reduce Trial, L-Plate, Left 003-A-00006R Reduce Trial, L-Plate, Right NOTE: RIVAL REDUCE plate trials can be contoured by using plate bending irons and applied to the application site to identify the best fit. 003-A Reduce Trial, T-Plate, Small 003-A Reduce Trial, T-Plate, Large 003-A Reduce Trial, Y-Plate, Small 003-A Reduce Trial, Y-Plate, Large 003-A Reduce Trial, Straight Plate, 3 Hole 003-A Reduce Trial, Straight Plate, 4 Hole 003-A Reduce Trial, Straight Plate, 6 Hole 003-A Reduce Trial, H-Plate, 12mm 003-A Reduce Trial, H-Plate, 15mm 003-A Reduce Trial, H-Plate, 17mm 003-A Reduce Trial, H-Plate, 20mm 003-A Reduce Trial, H-Plate, 22mm 003-A Reduce Trial, H-Plate, 25mm 003-A Reduce Trial, H-Plate, 30mm 003-A Reduce Trial, Box Plate, 18mm 003-A Reduce Trial, Box Plate, 20mm 003-A Reduce Trial, Box Plate, 22mm 003-A Reduce Trial, Box Plate, 25mm 003-A Reduce Trial, Box Plate, 30mm Fig. 1

8 8 OPERATIVE TECHNIQUE Temporary Fixation INSTRUMENTS Part# Description REDUCE PLATES 003-B T-Plate, Small 003-B T-Plate, Large 003-C Y-Plate, Small 003-C Y-Plate, Large 003-D Straight Plate, 3 Hole 003-D Straight Plate, 4 Hole 003-D Straight Plate, 6 Hole 003-E-00001L L-Plate, Left 003-E-00001R L-Plate, Right Open the selected sterile RIVAL REDUCE Plate. If necessary, contour the selected plate to fit specific anatomy and fixation options by using plate bending irons available in the RIVAL Instrumentation. Place the plate on the bone, confirm appropriate contour and use olive wires to provisionally fix the plate to the bone (Fig. 2). WARNING: Excessive bending and re-bending of titanium plates can lead to plate failure and is not recommended. NOTE: Care must be taken to consider adjacent joints when planning plate positioning and screw placement not perpendicular to the plate. 003-F Box Plate, 18mm 003-F Box Plate, 20mm 003-F Box Plate, 22mm 003-F Box Plate, 25mm 003-F Box Plate, 30mm 003-H H-Plate, 12mm 003-H H-Plate, 15mm 003-H H-Plate, 17mm 003-H H-Plate, 20mm 003-H H-Plate, 22mm 003-H H-Plate, 25mm 003-H H-Plate, 30mm PLATE BENDING IRONS 002-A Plate Bending Iron, Left 002-A Plate Bending Iron, Right Fig A-2P003 Olive Wires (Kit of 2)

9 OPERATIVE TECHNIQUE 9 Screw Selection All screw holes on the RIVAL REDUCE plates accommodate RIVAL s locking and non-locking bone screws with a diameter of 2.0mm and 2.7mm. Select the appropriate screw diameter and type (see Table 1 pag. 4) based upon patient s bone quality and anatomy. Pre-drilling INSTRUMENTS Part# Description 002-A Standard Drill Bit, D 1.5mm X 125mm, 002-A Standard Drill Bit, D 2.0mm X 125mm, 002-A Drill Guide (Locking And Non-Locking) 002-A Locking Drill Sleeve Use appropriate sterile packed drill bits in conjunction with the drill guides found in the RIVAL Instrumentation to prepare the screw holes (see Table 1 pag. 4). Ensure complete drilling through both cortices (Fig. 3). WARNING: Do not use the locking drill sleeve as a bending iron for the plates as this may damage the threads and preclude the use of the locking mode. PRECAUTION: It is particularly important to frequently screen with an image intensifier during drilling. Fig. 3 Screw length selection INSTRUMENTS Part# Description 002-A Depth Gauge With Hook Insert the depth gauge through the pilot hole and hook the far cortex (Fig. 4). Press the barrel of the depth gauge to the surface of the plate to determine the screw length. Image intensifier may be used to visualize the depth gauge and confirm correct screw position especially when screws are not placed perpendicular to the plate. Fig. 4

10 10 OPERATIVE TECHNIQUE Screw Insertion INSTRUMENTS Part# Description 002-D-200XX Non-Locking Screws D 2.0mm 002-E-200XX Locking Screws D 2.0mm 002-D-270XX Non-Locking Screws D 2.7mm 002-E-270XX Locking Screws D 2.7mm 002-A Hex Screw Driver, For 2.0/2.7/3.2mm Screws, Open the sterile packed screw to the corresponding diameter and length identified. Use the hex screwdriver found in the RIVAL Instrumentation to advance the screw into place (Fig. 5). NOTE: Final screw tightening is not recommended until all desired screws have been inserted into the plate. WARNING: Screws must not be over-tightened during insertion. Excessive over-tightening will compromise the integrity of the screw head, resulting in possible screw stripping/ breakage. WARNING: Excessive tightening of a locking bone screw may lead to stripping of the locking threads. In the event that a locking bone screw thread strips out, replace the locking screw with a non-locking screw. PRECAUTION: It is particularly important to frequently screen with an image intensifier during screw insertion. Fig. 5 Compression Feature Compression across a fracture/osteotomy site can be achieved using the oblong compression screw slot on the RIVAL REDUCE plates.

11 OPERATIVE TECHNIQUE 11 Repeat drill, measuring, and placement of screws in the remaining holes as required (Fig. 6). NOTE: Remember to use the appropriate drill size for the desired screw diameter. Fig. 6 Final screw tightening When all desired screws have been inserted into the plate, remove provisional fixation and perform final manual tightening with consideration (Fig. 7). Fig.7

12 12 OPERATIVE TECHNIQUE Plate and Screw Removal INSTRUMENTS Part# Description 002-A Hex Screw Driver, For 2.0/2.7/3.2mm Screws, 003-A Soft Tissue Elevator If the plate and screws need to be removed, perform appropriate surgical incisions to adequately expose the implant. If necessary, remove overgrown bone to expose entire screw heads. Use the hex screwdriver for 2.0/2.7/3.2mm screws found in the RIVAL Instrumentation to remove each screw from the plate (Fig. 8). Use a soft tissue elevator or other general surgical instrument to lift off the plate from the bone (Fig. 9). Fig. 8 Fig. 9

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16 Electronic Instructions for use available at the website Electronic Instructions for use - Minimum requirements for consultation: Internet connection (56 kbps) Device capable to visualize PDF (ISO/IEC ) files Disk space: 50Mbites Free paper copy can be requested to customer service (delivery within 7 days): tel , fax , customerservice@orthofix.it Distributed by: Manufactured by: ORTHOFIX Srl Via Delle Nazioni 9, Bussolengo (Verona), Italy Telephone , Fax Instructions for Use: See actual package insert for Instructions for Use. RI-1702-OPT-E0 D 09/17 Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Proper surgical procedure is the responsibility of the medical professional. Operative techniques are furnished as an informative guideline. Each surgeon must evaluate the appropriateness of a technique based on his or her personal medical credentials and experience. Please refer to the Instructions for Use supplied with the product for specific information on indications for use, contraindications, warnings, precautions, adverse reactions and sterilization.