Finished Product

AR-4166

Bohrhülse für variabel winkelstabile Schrauben, 3.0mm

Guía de perforación, bloqueo en ángulo variable, Ø 3 mm

AR-8933GV

3.0 mm VAL Locking Drill Guide, qty. 2

Bohrhülse für vari.winkelstabile Schrauben, 3.0mm, m Gewinde

Guía de perforación, bloqueo en ángulo variable, bloqueo, Ø 3 mm

AR-8933GVN

AR-8941BP

Screw Holding Forceps, Self-Retaining

Haltenzange für Low Profile Kortikalisschrauben

Pinzas de sujeción de tornillo con autorretención

AR-8941F

Bone Reduction Forceps, Curved, Pointed, qty 2

Moskitoklemme zur Reduktion von Knochenfragmenten, gebogen, spitz

Pinzas de reducción ósea, punta curvada y puntiaguda

Pinça para redução óssea, curva, pontiaguda

AR-8943-07

AR-8943-18

AR-8943-24

AR-8943-31

AR-8944-22

Schraubendreheraufsatz, Torx 10 (=2.74mm)

AR-8944DH

AR-8950-05

Locking Drill Guide, 3.0 mm, qty. 2

Bohrhülse / Tiefenmesser für 3.0mm winkelstabile Schrauben

Guía de perforación, con fijación, roscada, Ø 3 mm

Guia de perfuração, bloqueio, roscado, 3 mm

AR-8950-07

Guía para doblar, con fijación, Ø 3 mm

AR-8950-09

Handle, Quick Coupling Ratcheting, Cannulated

Handle, Quick Coupling Ratcheting, Cannulated

Punho, Lingueta de rápida acoplagem, canulado

AR-8950RH

Plate Cutter, Curved Cut, Mesh Plates

Plattenschneider, gebogen, für Maschenplatten

AR-8957-05

Plattenschneider, gerade, für Maschenplatten

AR-8957-06

Mesh Plate Instrument Case, Titanium

Instrumentencontainer für Titanmaschenplatten

AR-8957TC

AR-8957TS

Foot and Ankle

Product

Arthrex mesh plates are available in titanium or stainless steel and standard and shorts lengths. Surgeons may cut the plates to size. The plates are intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusion, and reconstruction of small bones and bone fragments of the hand/wrist, foot/ankle, and osteopenic bone.

Arthrex highlights the Mesh Plating System for patella fracture repair. The Mesh Plating System is offered in both titanium and stainless steel.

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Arthrex Mesh Plate for Patella Fracture

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Mesh Plating for Patella Fractures Surgical Technique Mesh Plating for Patella Fractures Introduction The Arthrex mesh plate is the first FDA-cleared plate for patella fracture indications in the United States. Patella fractures represent approximately 1% of all fractures1 and present a variety of fracture patterns, which can make osteosynthesis challenging. These fractures are the most common cause of disruption of the extensor mechanism and can result from direct, indirect, or combined trauma.2 The amount of comminution, degree of osteoporosis, and the natural forces across the patella create obstacles for reduction and adequate stabilization. Studies have shown significantly higher patellar stability and osteosynthesis rates with locked plates.1 Used in conjunction with the Patella Fracture Set, the Arthrex mesh plates can facilitate the fixation needs of these frequently challenging injuries. The 4.0 mm blunt-tip cannulated lag screws can be used with FiberTape® suture to create tension-band fixation or cannulated lag screws can be used with the stainless steel or titanium mesh plate to provide stable fixation for comminuted fracture patterns. Arthrex mesh plates are offered in standard and short lengths and surgeons may cut the plates to the desired size and shape for the fracture. Plate Features Stainless Steel Mesh Plate, long Stainless Steel Mesh Plate, short Titanium Mesh Plate, long Titanium Mesh Plate, short The Arthrex mesh plates are available in standard and short lengths. Surgeons can cut the plates to size to fit the specific fracture. Bending irons can be used to contour the plate to the patient’s anatomy. The stainless steel plates use 2.7 mm locking and nonlocking screws, while the titanium plates use 3.0 mm locking and nonlocking screws. The areas between screw fixation can be used as reattachment points for soft tissue or ligament bracing. In addition to the plate, a 4.0 mm blunt-tipped cannulated lag screw can be used to apply compression to patellar fragments. 01 I Mesh Plating for Patella Fractures Patient Positioning The patient is in supine position with the operated leg prepped and draped. Surgical Approach The paramedian/median approach (analogous to the approach in knee replacement), starting cranial to the patella and running centrally to the region of the tibial tubercle is a standard approach. Deep dissection involving the medial or lateral retinacula may be necessary to facilitate anatomic reduction of the articular surface. Surgical Technique 1 Reduce the bone fragments to the anatomic position using either small tenaculum or large Weber clamps. 2a After reducing the fracture, use the straight plate cutter to cut multiple rows to fit the anterior surface of the patella. 2b The curved plate cutter can be used for finer cuts around the screw holes. To help prevent sharp edges from causing soft-tissue irritation, place the plate into the jaws of the cutter as shown. Position the plate on the seating pin and cut as needed. Mesh Plating for Patella Fractures I 02 Surgical Technique 3 After the mesh plate is cut to the desired shape, the locking bending guide can be used to further shape the plate to match the patella surface. BB-Taks can be used to temporarily fix the plate to the bone. 5 Determine the screw length by measuring the guidewire with the over-the-wire depth gauge and insert the correct cannulated 4.0 mm lag screw. 03 I Mesh Plating for Patella Fractures 4 In addition to the plate, a 4.0 mm blunt-tip cannulated lag screw can be used to apply compression across fragments outside of the plate fixation. Use the 1.35 mm guidewire to check the screw trajectory and to measure the desired screw length prior to drilling with the 2.6 mm drill bit. 6 After confirming the screw length, over-drill the 1.35 mm guidewire with the 2.6 mm cannulated drill. Use the cannulated T15 driver to insert the 4.0 mm screw over the 1.35 mm guidewire. Surgical Technique 7 The locking drill guide is screwed into the locking holes before drilling. Ensure there are no guidewires or cannulated lag screws in the drill path. The screw length is determined by referencing the laser line on the 2.0 mm drill bit at the scale on the locking drill guide. 9 Screws must not enter the articulating surface of the patella. If fragment size allows, three screws should be used for each fragment. The screw heads should sit flush with the plate. 8 Leave the 2.7 mm low-profile screws fixed into the plate until the desired fixation is reached. Secure the locking screws with the T10 hexalobe driver. 10 Final fixation. Mesh Plating for Patella Fractures I 04 Contraindictions 1. Insufficient quantity or quality of bone. 3. Foreign-body sensitivity. Where material sensitivity is suspected, appropriate tests should be conducted before implantation to rule out sensitivity. 6. The use of this device may not be suitable for patients with insufficient or immature bone. The physician should carefully assess bone quality before performing orthopedic surgery on patients who are skeletally immature. The use of this medical device and the placement of hardware or implants must not bridge, disturb, or disrupt the growth plate. 4. Any active infection or blood supply limitations. 7. Do not use for surgeries other than those indicated. 2. Blood supply limitations and previous infections, which may retard healing. 5. Conditions that tend to limit the patient’s ability or willingness to restrict activities or follow directions during the healing period. Warnings 1. An internal fixation device must never be reused. 2. All metallic implant devices used for this surgical procedure should have the same metallurgical composition. 3. Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weightbearing or other unsupported stress. The fixation provided by this device should be protected. The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device. 4. Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the device, are important considerations in the successful utilization of this device. The appropriate Arthrex delivery system is required for proper implantation of the device. 5. Any decision to remove the device should take into consideration the potential risk to the patient of a second surgical procedure. Device removal should be followed by adequate postoperative management. 6. Detailed instructions on the use and limitations of this device should be given to the patient. 7. This is a single-use device. Reuse of this device could result in failure of the device to perform as intended and could cause harm to the patient and/or user. 8. Removal of supplemental fixation after healing. If the supplemental fixation is not removed following the completion of its intended use, any of the following complications may occur: (1) corrosion, with localized tissue reaction or pain; (2) migration of implant position resulting in injury; (3) risk of additional injury from postoperative trauma; (4) bending, loosening, and/or breakage, which could make removal impractical or difficult; (5) pain, discomfort, or abnormal sensations due to the presence of the device; (6) possible increased risk of infection; and (7) bone loss due to stress shielding. The surgeon should carefully weigh the risks versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management to avoid refracture. Adverse Effects 1. Infections, both deep and superficial. 2. Foreign body reactions. 05 I Mesh Plating for Patella Fractures 3. Mesh Plates for Patella Fracture only: Joint stiffness, malunion, non-union, device breakage, need for additional surgery, and screws entering the joint or damaging the articular surface. Ordering Information Mesh Plating System, Stainless Steel (AR-8957S) Product Description Item Number Instruments Mesh Plating System, Titanium (AR-8957TS) Product Description Item Number Instruments Trim-It™ Depth Gauge, small AR-4166 Trim-It Depth Gauge, small AR-4166 Bending Pliers, qty. 2 AR-8941BP Drill Guide, VAL, 3 mm AR-8933GV Screw Holding Forceps, self-retaining AR-8941F Drill Guide, VAL, 3 mm, qty. 4 AR-8933GVN Bone Reduction Forceps, curved, pointed, qty. 2 AR-8943-07 Bending Pliers, qty. 2 AR-8941BP Bending Iron Plate, qty. 2 AR-8943-18 Screw Holding Forceps, self-retaining AR-8941F Weber Clamp AR-8943-24 Bone Reduction Forceps, curved, pointed, qty. 2 AR-8943-07 Drill Guide, 2.0 mm/2.7 mm AR-8827D-02 Bending Iron Plate, qty. 2 AR-8943-18 Driver, T10 hexalobe, qty. 2 AR-8944DH Weber Clamp AR-8943-24 Drill Guide, locking, threaded, 3 mm, qty. 2 AR-8950-07 Drill Guide, 2.0 mm/3.0 mm AR-8943-31 Locking Bending Guide, 3 mm, qty. 2 AR-8950-09 Driver, T10 hexalobe, qty. 2 AR-8944DH Handle QC, ratcheting, cannulated AR-8950RH Drill Guide, locking, threaded, 3 mm, qty. 2 AR-8950-07 Plate Cutter, curved cut AR-8957-05 Locking Bending Guide, 3 mm, qty. 2 AR-8950-09 Plate Cutter, straight cut AR-8957-06 Handle QC, ratcheting, cannulated AR-8950RH Instrument Case AR-8957C Plate Cutter, curved cut AR-8957-05 Plate Cutter, straight cut AR-8957-06 Instrument Case AR-8957TC Plates (Order Separately) Mesh Plate, short, qty. 2 Mesh Plate, long, qty. 2 AR-8957-04 AR-8957-02 Screws, Stainless Steel (Order Separately) Low Profile Screws, cortical, 2.7 mm × 10 mm-50 mm (2 mm increments) AR-8827-10 – 50 Low Profile Locking Screws, 2.7 mm × 10 mm-50 mm (2 mm increments) AR-8827L-10 – 50 Plates (Order Separately) Mesh Plate, short, qty. 2 Mesh Plate, long, qty. 2 AR-8957-03 AR-8957-01 Screws, Titanium (Order Separately) Low Profile Screws, cortex, Ti, 3.0 mm × 10 mm-50 mm (2 mm increments) AR-8933-10 – 50 VAL Screw, Ti, 3 mm × 10 mm-40 mm, qty. 4 AR-8933V-10 – 40 Disposables BB-Tak, qty. 2 AR-13226 BB-Tak, threaded, qty. 2 AR-13226T Guidewire, .045 in, qty. 3 AR-8933K Guidewire w/ Double Trocar Tip, .045 in, qty. 3 AR-8933KD Guidewire w/ Trocar Tip, threaded, .045 in, qty. 3 AR-8933KT Guidewire w/ Trocar Tip, .062 in, qty. 3 AR-8941K Guidewire w/ Trocar Tip, threaded, .062 in, qty. 3 AR-8941KT Drill Bit, 2 mm, qty. 2 AR-8944-22 Drill Bit, 2.7 mm AR-8827D-01 Drill Bit, 3.0 mm AR-8950-05 Only included in AR-8957TS Mesh Plating for Patella Fractures I 06 Ordering Information Patella Fracture Set (AR-5050S) Product Description Item Number Instruments Over-the-Wire Depth Gauge AR-5050-02 AO Pull Release Ratcheting Driver AR-5050-03 Sternal Wire Driver, qty. 2 AR-5050-04 Small Weber Clamp, long throw, qty. 2 AR-5050-05 Patellar Measurement Device AR-5050-06 Drill Guide, 2.0 mm/1.6 mm AR-5050-07 Stout Wire Cutter, 9 in AR-5050-08 Pliers, medium length AR-5050-09 Passer, cerclage wire, bent AR-5050-10 Parallel Drill Guide, patella fracture AR-5050-11 Screw Holding Forceps, self-retaining AR-8941F Drill Bit, cannulated, 2.6 mm AR-8943-02 Drill Guide, 2.6 mm/1.35 mm AR-8943-03 Bone Tap, cannulated, 2.6 mm AR-8943-06 Screwdriver, T15 hexalobe, cannulated AR-8943-09 Holding Sleeve for 2.7 mm, 3.5 mm, and 4.0 mm screws AR-8943-11 Driver, cannulated, QC, T15 hexalobe AR-8943-12 Depth Device, 2.7 mm/3.5 mm/4.0 mm, low-profile AR-8943-15 Freer Elevator AR-8943-19 Sharp Hook AR-8943-21 Weber Clamp AR-8943-24 Patella Fracture Set Case AR-5050C Implants Low Profile Screws, cannulated, blunt tip, 4.0 mm × 24 mm-60 mm (2 mm increments) AR-5051-24 – 60 Optional FiberTape Suture w/ Needle, 17 in AR-7237-17LN References 1. Müller EC, Frosch K-H. Functional outcomes of revision osteosynthesis after failure of surgical treatment of patellar fractures. J Knee Surg. 2019 Jul 9. https://doi.org/10.1055/s-0039-1692673 2. Pengas IP, Assiotis A, Khan W, Spalding T. Adult native knee extensor mechanism ruptures. Injury.2016;47(10):2065–2070. This description of technique is provided as an educational tool and clinical aid to assist properly licensed medical professionals in the usage of specific Arthrex® products. As part of this professional usage, the medical professional must use their professional judgment in making any final determinations in product usage and technique. In doing so, the medical professional should rely on their own training and experience, and should conduct a thorough review of pertinent medical literature and the product’s Directions For Use. Postoperative management is patient specific and dependent on the treating professional’s assessment. Individual results will vary and not all patients will experience the same postoperative activity level and/or outcomes. View U.S. patent information at www.arthrex.com/corporate/virtual-patent-marking © 2020 Arthrex, Inc. All rights reserved. | www.arthrex.com | LT1-000190-en-US_A

Mesh Plating for Patella Fractures

Mesh Plate for Foot Fractures and Medial Column Arthrodesis Surgical Technique Mesh Plating Technique The Arthrex Mesh Plate is available in titanium or stainless steel and standard and short lengths. Surgeons may cut the plate to size. The plates are intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusions, and reconstruction of small bones and bone fragments of the hand/wrist, foot/ankle, and osteopenic bone. Titanium Mesh Plate, long Titanium Mesh Plate, short Stainless Steel Mesh Plate, long Stainless Steel Mesh Plate, short Mesh Plating Technique I 01 Ordering Information Mesh Plating System, Stainless Steel Product Description Item Number Mesh Plating System, Stainless Steel AR-8957S Instruments Trim-It™ Depth Gauge, small AR-4166 Drill Bit, 2.7 mm AR-8827D-01 Drill Guide, 2.0 mm/2.7 mm AR-8827D-02 Bending Pliers, qty. 2 AR-8941BP Screw Holding Forceps, self-retaining AR-8941F Bone Reduction Forceps, curved, pointed, qty. 2 AR-8943-07 Bending Iron Plate, qty. 2 AR-8943-18 Weber Clamp AR-8943-24 Drill Bit, 2 mm, qty. 2 AR-8944-22 Driver, T10 hexalobe, qty. 2 AR-8944DH Drill Guide, locking, threaded, 3 mm, qty. 2 AR-8950-07 Locking Bending Guide, 3 mm, qty. 2 AR-8950-09 Handle QC, ratcheting, cannulated AR-8950RH Plate Cutter, curved cut AR-8957-05 Plate Cutter, straight cut AR-8957-06 Instrument Case AR-8957C Plates Mesh Plate, short Mesh Plate, long AR-8957-04 AR-8957-02 Screws, Stainless Steel Low Profile Screws, cortical, 2.7 mm × 10 mm-50 mm (2 mm increments) AR-8827-10 – 50 Low Profile Screws, locking, 2.7 mm × 10 mm-50 mm (2 mm increments) AR-8827L-10 – 50 Mesh Plating System, Titanium Product Description Item Number Mesh Plating System, Titanium AR-8957TS Instruments Trim-It Depth Gauge, small AR-4166 Drill Guide, VAL, 3 mm AR-8933GV Drill Guide, VAL, 3 mm, qty. 4 AR-8933GVN Bending Pliers, qty. 2 AR-8941BP Screw Holding Forceps, self-retaining AR-8941F Bone Reduction Forceps, curved, pointed, qty. 2 AR-8943-07 Bending Iron Plate, qty. 2 AR-8943-18 Weber Clamp AR-8943-24 Drill Guide, 2.0 mm/3.0 mm AR-8943-31 Drill Bit, 2.0 mm, qty. 2 AR-8944-22 Driver, T10 hexalobe, qty. 2 AR-8944DH Drill Bit, 3.0 mm AR-8950-05 Drill Guide, locking, threaded, 3 mm, qty. 2 AR-8950-07 Locking Bending Guide, 3 mm, qty. 2 AR-8950-09 Handle QC, ratcheting, cannulated AR-8950RH Plate Cutter, curved cut AR-8957-05 Plate Cutter, straight cut AR-8957-06 Instrument Case AR-8957TC Plates Mesh Plate, short Mesh Plate, long AR-8957-03 AR-8957-01 Screws, Titanium Low Profile Screws, cortical, 3.0 mm × 10 mm-50 mm (2 mm increments) AR-8933-10 – 50 VAL Screws, 3 mm × 10 mm-40 mm (2 mm increments) AR-8933V-10 – 40 I Mesh Plating Technique02 Mesh Plating Technique After preparing and reducing the joint surfaces, fracture, or osteotomy site, use the straight plate cutter to cut multiple rows to fit the area. Cut plate The curved cut plate cutter can be used for finer cuts around the screw holes. To help prevent sharp edges from causing soft-tissue irritation, place the plate into the jaws of the cutter as shown. 1) Position the plate on the seating pin. 2) Position the plate under the notched pin. 3) Cut. Note: User should maintain a minimum of 2 rows and 2 columns to ensure structural strength. Precautions: ■ Do not bend the plate near the locking hole. Bending the plate near the locking hole can distort the holes, which may prohibit the screw from locking. ■ Repeated bending of the plate at the same location, or creating excessive acute angles, may lead to premature plate fatigue, failure, and/or breakage in situ. ■ Screws should be inserted by hand and not with powered equipment. 1 2 Mesh Plating Technique I 03 Mesh Plating Technique Drill for variable-angle locking screws (titanium plates only) Variable-angle locking (VAL) screws can be manipulated around the independent lag screw or existing implants. Begin by placing the VAL drill guide in the hole to be drilled. Precaution: To ensure that the drill sleeve is locked correctly, do not angle the drill bit in excess of ±15° from the nominal trajectory of the hole. Verify the drill bit angle and depth under image intensifier control. If incorrect, drill at a different angle and verify again. Use the corresponding depth gauge to measure the correct screw length. Position plate Position the plate over the osteotomy, joint, or fracture site. If necessary, fix provisionally with K-wires, BB-Taks, and/or reduction forceps. Place the plate on the bone, ensuring appropriate placement according to the specific procedure. 4 3 I Mesh Plating Technique04 Mesh Plating Technique Drill and insert cortical screws Insert independent cortical screws according to the corresponding indication and situation. Use the lag screw technique to achieve additional compression. For the titanium 3.0 mm cortical screws, use the 3.0 mm drill guide and predrill the screw hole with the 2.0 mm drill bit. For the stainless steel 2.7 mm cortical screws, use the 2.7 drill guide and predrill the screw hole with the 2.0 mm drill bit. Determine the screw length with the depth gauge and insert the cortical screws manually. Final construct for a medial column fusion. Final construct for a navicular fracture. Final construct for a cuboid fracture. 5a 6 7 5 Mesh Plating Technique I 05 Contraindictions 1. Insufficient quantity or quality of bone. 2. Blood supply limitations and previous infections, which may retard healing. 3. Foreign-body sensitivity. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation. 4. Any active infection or blood supply limitations. 5. Conditions that tend to limit the patient’s ability or willingness to restrict activities or follow directions during the healing period. 6. The use of this device may not be suitable for patients with insufficient or immature bone. The physician should carefully assess bone quality before performing orthopedic surgery on patients who are skeletally immature. The use of this medical device and the placement of hardware or implants must not bridge, disturb, or disrupt the growth plate. 7. Do not use for surgeries other than those indicated. Warnings 1. An internal fixation device must never be reused. 2. All metallic implant devices used for this surgical procedure should have the same metallurgical composition. 3. Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress. The fixation provided by this device should be protected. The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device. 4. Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the device, are important considerations in the successful utilization of this device. The appropriate Arthrex delivery system is required for proper implantation of the device. 5. Any decision to remove the device should take into consideration the potential risk to the patient of a second surgical procedure. Device removal should be followed by adequate postoperative management. 6. Detailed instructions on the use and limitations of this device should be given to the patient. 7. This is a single-use device. Reuse of this device could result in failure of the device to perform as intended and could cause harm to the patient and/or user. 8. Removal of supplemental fixation after healing. If the supplemental fixation is not removed following the completion of its intended use, any of the following complications may occur: (1) corrosion, with localized tissue reaction or pain; (2) migration of implant position resulting in injury; (3) risk of additional injury from postoperative trauma; (4) bending, loosening, and/or breakage, which could make removal impractical or difficult; (5) pain, discomfort, or abnormal sensations due to the presence of the device; (6) possible increased risk of infection; and (7) bone loss due to stress shielding. The surgeon should carefully weigh the risks versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management to avoid re-fracture. This description of technique is provided as an educational tool and clinical aid to assist properly licensed medical professionals in the usage of specific Arthrex products. As part of this professional usage, the medical professional must use their professional judgment in making any final determinations in product usage and technique. In doing so, the medical professional should rely on their own training and experience and should conduct a thorough review of pertinent medical literature and the product’s directions for use. Postoperative management is patient-specific and dependent on the treating professional’s assessment. Individual results will vary and not all patients will experience the same postoperative activity level or outcomes. View U.S. patent information at www.arthrex.com/corporate/virtual-patent-marking © 2019 Arthrex, Inc. All rights reserved. | www.arthrex.com | LT1-00104-EN_C

Mesh Plate for Foot Fractures and Medial Column Arthrodesis

Charles J. Jordan, MD (Miami, FL), discusses using the Arthrex Mesh Plating System clinically for patella fractures. The Arthrex mesh plate is the first and only plate with FDA clearance for patella fracture indications.

Mesh Plating System, Titanium