Modular Sternal Cable System. Flexibility and strength in sternal closure and repair.

Transcription

1 Modular Sternal Cable System. Flexibility and strength in sternal closure and repair. Multiple closure options Stable fixation in all configurations Improved strength and flexibility compared to wire

2 Modular Sternal Cable System Modular Sternal Closure Options Flexibility in sternal closure due to modular options Intraoperative choice depending on patient s needs Stable fixation in all configurations Sternal cable with an improved strength and stability compared to wire* Sternal cannulated screws for reinforcement of sternal bone quality Sternal reconstruction plates for repair of transverse fractures Peristernal using cable with needle Transsternal using cable and cannulated screws Sternal reconstruction using cable, cannulated screws and plates * See page 4 for mechanical testing results Synthes CMF Modular Sternal Cable System

3 1.0 mm Sternal Cable Multifilament structure provides improved strength and flexibility A greater bone-to-implant contact area than wire provides a reduced risk for cutting through the sternal bone 7 x 19 filaments Cross sectional view, 1.0 mm diameter cable Flexible cable contours to the shape of the sternum Ferrule is crimped onto the end of the cable to secure the finished construct and avoid sharp edges Available with or without a quick- release needle Ferrule Parallel end fitting Cable Cable with needle Synthes CMF 1

4 Modular Sternal Cable System continued 4.5 mm Sternal Cannulated Screws Easily insert into the manubrium or sternal body using the adjustable screwdriver blade with spade point Eliminate the need to insert a needle through the sternum Cannulation provides a metal surface for cable to pass through for reinforcement in weak cancellous bone Blunt tip allows safe bicortical insertion Available in lengths from 8 mm to 28 mm, in 1 mm increments 4.5 mm Sternal Reconstruction Plates For reconstruction of sternal transverse fractures Distribute forces along the length of the sternum, reducing the likelihood of bony failure Attach to the sternum with cannulated screws Contourable, to closely match the sternum With transverse holes for peristernal cable passage Available in several lengths (80 mm 192 mm) to minimize intraoperative plate cutting 2 Synthes CMF Modular Sternal Cable System

5 Tensioner/Crimper/Cutter Single, multipurpose instrumentation Force limiting for easy handling and consistent tensioning 1 Tensioning wheel with force limiting 2 Trigger to crimp and cut the cable 3 Instrument nose for ferrule insertion Tensioning of the cable Crimping the ferrule and cutting the cable with single action Indications Sternal repair and reconstruction Synthes CMF 3

6 Stable Fixation Implant construct testing Peak load in poor quality bone until cut-through 1 The Modular Sternal Cable System provides increased resistance to implant cut-through in the sternum. Peak Force (N) % % 50 0 SST Wire Synthes Sternal Cable Synthes Sternal Cable and Cannulated Screws Tensile load at failure of the implants 2 Force (N) 1200 The Modular Sternal Cable System provides greater strength % % SST Wire Synthes Sternal Cable Synthes Sternal Cable and Cannulated Screws Fatigue load 3 Maximum load to reach 800,000 cycles** The Modular Sternal Cable System shows a higher resistance to fatigue. Peak Force (N) Synthes Mechanical Test Numbers: MT03-005, MT and MT All tests were performed on composite polyurethane foam test blocks each measuring 165 mm in length x 40 mm in width x 10 mm thick. The test blocks were composed of an inner (cancellous) core of 5 lb/ft 3 polyurethane foam with a 1.25 mm thick (cortical) shell of 10 lb/ft 3 polyurethane foam laminated to the exterior. All samples were loaded at a rate of 10 mm/minute. 2. Synthes Mechanical Test Number MT All samples were loaded at a rate of 10 mm/minute. 3. Synthes Mechanical Test Numbers: SET_ and SET_ ** Estimating 20 breaths per minute 24 hours a day, 800,000 cycles would be the equivalent of about 4 weeks SST Wire Synthes Sternal Cable Synthes Sternal Cable and Cannulated Screws 4 Synthes CMF Modular Sternal Cable System

7 Modular Sternal Cable System Sternal Cable Instrument Set ( ) Graphic Case Graphic Case, for Modular Sternal Cable System Cable Instrument Set Instruments Tensioner/Crimper/Cutter, for 1.0 mm Sternal Cable, 2 ea Cable Cutter, standard Sternal Reduction Forceps, angled with teeth, 2 ea Bone Reduction Forceps, large, 2 ea. Implants mm Sternal Crimping Ferrule, long, 1 pkg. of mm Sternal Parallel End Fitting, 1 pkg. of 5 Also Available 1.0 mm Sternal Cables, with long crimping ferrule and parallel end fitting, sterile S (without needle), 1 per pkg S (without needle), 3 per pkg S with needle, 1 per pkg S with needle, 3 per pkg Sternal Reduction Forceps Synthes CMF 5

8 Modular Sternal Cable System 4.5 mm Cannulated Screw and Plate Set ( ) Graphic Cases, Modules and Screw Length Markers Modular Sternal Cable System, 4.5 mm Cannulated Screw and Plate Set Graphic Case Screw Module, for 4.5 mm Sternal Cannulated Screws Plate Module, for 4.5 mm Sternal Reconstruction Plates Screw Length Markers, 8 mm 26 mm, (10/pkg.), 1 pkg. of each Instruments Depth Gauge, for 4.5 mm Sternal Cannulated Screws Screwdriver Handle with hex coupling, medium, 2 ea Combination Bending Pliers, for 2.0 mm/2.4 mm plates Bending Template, 37 holes, for reconstruction plates, 2 ea mm Awl, hex coupling Obturator, for Sternal Cable Passer, 37 mm Cable Passer, for 1.0 mm Sternal Cable mm Hexagonal Adjustable Screwdriver Blade, with spade point, hex coupling, 2 ea. Implants 4.5 mm Sternal Cannulated Screws ea.: 8 mm, 9 mm, 25 mm and 26 mm ea.: 10 mm 24 mm 4.5 mm Sternal Reconstruction Plates, 4 ea holes, 80 mm holes, 96 mm holes, 112 mm holes, 128 mm holes, 144 mm holes, 160 mm holes, 176 mm holes, 192 mm Synthes CMF Modular Sternal Cable System

9 Modular Sternal Cable System 4.5 mm Cannulated Screw Set ( ) Graphic Cases, Modules and Screw Length Markers Modular Sternal Cable System Cannulated Screw Set Graphic Case Screw Module, for 4.5 mm Sternal Cannulated Screws Screw Length Markers, 8 mm 26 mm, (10/pkg.), 1 pkg. of each Instruments Depth Gauge, for 4.5 mm Sternal Cannulated Screws Screwdriver Handle with hex coupling, medium, 2 ea mm Awl, hex coupling Obturator, for Sternal Cable Passer, 37 mm Cable Passer, for 1.0 mm Sternal Cable mm Hexagonal Adjustable Screwdriver Blade, with spade point, hex coupling, 2 ea. Implants 4.5 mm Sternal Cannulated Screws ea.: 8 mm, 9 mm, 25 mm and 26 mm ea.: 10 mm 24 mm Also Available mm Sternal Cannulated Screws, mm 28 mm Screw Length Markers, mm 28 mm Replacement Blade, for 4.5 mm Hexagonal Adjustable Screwdriver ( ) Synthes CMF 7

10 Modular Sternal Cable System Compact 4.5 mm Cannulated Screw and Plate Set ( ) Graphic Case, Module and Screw Length Markers Graphic Case for Compact 4.5 mm Cannulated Screw and Plate Set Compact 4.5 mm Cannulated Screw and Plate Module Screw Length Markers, 8 mm 26 mm, (10/pkg.), 1 pkg. of each Instruments Depth Gauge, for 4.5 mm Sternal Cannulated Screws Screwdriver Handle with hex coupling, medium Ratcheting Screwdriver Handle, 2 ea Combination Bending Pliers, for 2.0 mm/2.4 mm plates Bending Template, 37 holes, for reconstruction plates, 2 ea mm Awl, hex coupling Obturator, for Sternal Cable Passer, 37 mm Cable Passer, for 1.0 mm Sternal Cable mm Hexagonal Adjustable Screwdriver Blade, with spade point, hex coupling, 2 ea. Implants 4.5 mm Sternal Cannulated Screws ea.: 8 mm, 9 mm, 10 mm, 11 mm and 26 mm ea.: 12 mm 25 mm 4.5 mm Sternal Reconstruction Plates, 2 ea holes, 80 mm holes, 96 mm holes, 112 mm holes, 128 mm holes, 144 mm holes, 160 mm holes, 176 mm holes, 192 mm Also Available mm Sternal Cannulated Screws, 27 mm mm Sternal Cannulated Screws, 28 mm Screw Length Marker, 27 mm Screw Length Marker, 28 mm Label Clips, for sternal plates LC for plate LC for plate LC for plate LC for plate LC for plate LC for plate LC for plate LC for plate LC for Sternal Module LC blank 8 Synthes CMF Modular Sternal Cable System

11 Synthes In the Service of Health Synthes is an internationally leading company in medical technology. Over 8,400 Synthes employees worldwide are involved in serving the needs of surgeons, surgical support staff and patients. Synthes a company specializing in the field of osteosynthesis develops, produces and markets surgical instruments, implants, and biomaterials for the surgical treatment of bone fractures and reconstructions of the human skeleton and its associated soft tissue. The main goal of Synthes is to provide safe and highly advanced implants, surgical instruments and technologies that enable reliable operations, fast healing and a complaint-free life after surgery. We gua rantee high quality, continuous innovation and a focused customer orientation. AO A medically-oriented nonprofit organization in the service of surgeons and patients Synthes works closely with the AO Foundation, and is licensee of the products bearing the brand name Synthes. AO stands for Arbeitsgemeinschaft für Osteosynthesefragen (Association for the Study of Internal Fixation). The foundation boasts more than 5,000 surgeons who participate in AO activities throughout the world one of the largest networks in the field of medicine. In the professional world, this surgeon-led, scientific nonprofit organization focused on treating bone fractures and diseases of the musculoskeletal system is a pioneer in research, documentation and development. The Technical Commission of the AO monitors the implementation of medical studies of new products, as a fully independent institution administered by health professionals. Only when it confirms the effectiveness and quality of a product does it award the seal of quality of the Synthes brand. Surgeons throughout the world place great trust in Synthes products because they know they have been carefully evaluated and tested. Yet even the best implants and instruments are useless if they are not used properly. AO International, the arm of the foundation responsible for training, annually organizes more than 160 AO courses throughout the world that offer practical exercises and discussions. Since the beginnings of the AO, experienced AO physicians have provided theoretical and practical training for more than 500,000 surgeons and more than 150,000 surgical support staff members. Synthes products are a familiar sight in nearly every operating room in the world. AO Foundation, Davos, Switzerland The AO Foundation offers numerous training courses worldwide. Synthes CMF 9

12 Synthes CMF 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) Synthes (Canada) Ltd Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 6/08 J6131-C