Catalog–Trauma2011

Instruments and implants approved by the AO Foundation

Implants

Instruments

Sets

Historical Background

The Association for the Study of Internal Fixation (in German:Arbeitsgemeinschaft für Osteosynthesefragen—AO) was founded inSwitzerland in 1958 by a group of surgeons interested in effecting betterresults in the operative treatment of fractures.

The AO sought to refine and increase the reliability of internal fixationtechniques through biological and metallurgical research, as well as throughthe exchange of practical and scientific experiences in treating fractures,osteotomies and nonunions.

Close cooperation between members of the AO, Synthes (USA), the RobertMathys Company at Bettlach, the Stratec Medical Company at Waldenburg,the AO Research Institute at Davos, and many scientific collaborators inSwitzerland and abroad led to the development of standardized instrumentsand implants for internal fixation.

These instruments and implants are systematically evaluated in clinical use byAO members before the products are made generally available, and theDocumentation Center in Davos records cases, collects follow-up data, andassesses results.

Rapidly increasing interest in internal fixation techniques around the world ledto the formation of AO International. This organization assists in and promoteseducation, research and teaching in the field of internal fixation throughgrants, AO courses, and educational fellowships.

All these efforts have established an excellent reputation for the AO Systemfrom which evolved the instruments and implants presented in this catalog.

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Terms and Conditions

ORDERING INFORMATION1-800-523-0322Fax toll free: 1-800-Synthes (796-8437)

EDI (Electronic Data Input), for information call: 1-800-523-0322Internet Order Processing, for inforamtion call: 1-800-523-0322

Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380

TERMS: NET 30 DAYS

FOB shipping point: Monument, CO

SERVICEA Return Authorization number is required. Call 1-800-288-6698

Ship all items for service to:

Synthes (USA)Attn: Service Department1101 Synthes AvenueMonument, CO 80132

RETURNS• Call Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) number.• Clearly mark package with RA number, and ship to: Synthes (USA) Attn: Returns Department 1101 Synthes Avenue Monument, CO 80132• No product may be returned for credit once that item has been removed from its original sterile or nonsterile package, or

after 90 days from invoice date.• If a temperature-sensitive product is received with an activated temperature sensitive label, the customer must report this

to Synthes Customer Relations immediately for credit and replacement. No credit or replacement will be issued for suchproduct unless reported within 24 hours of receipt of shipment.

• Instruments which are made on special request, even if unopened, may not be returned to Synthes for credit under anycircumstances.

• A Return Authorization number and a copy of the invoice or packing slip must accompany all returns.• All returns after 30 days from date of invoice are subject to a minimum restocking fee of 5%.• Credit for returned goods will only be issued upon Synthes (USA) determination of acceptable condition.

IN CANADATo order, call Customer Service: 1-800-668-1119 (English) 1-800-461-3243 (French)All other inquiries: 1-888-855-5513Fax: 905-567-3185Address correspondence and returns to: Synthes (CANADA) LTD. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9

Calceon, chronOS, Combi, DCP, DCS, DHHS, DHS, Fastight, LC-DCP, LCP, Norian, SRS, TraumaFix and Synthes are trademarks of Synthes, Inc. or its affiliates.

© 2006 Synthes, Inc. or its affiliates. All rights reserved. Printed in U.S.A. 2011 J4200-C

No extracts or copies of this catalog may be made without the written permission of Synthes, Inc. All Synthes catalogs and price lists remain the property of Synthes and may only be used in connection with the instruments and implants distributed by Synthes.

Terms and Conditions — continued

SYNTHES WARRANTY POLICYSynthes offers a lifetime warranty for catalog instruments purchased from Synthes. This warranty presumes that theinstruments are used with Synthes implants under normal operating conditions, and with established AO techniques. Excepted from this warranty are items which have been abused and those that become unserviceable through prolonged use.• Warranty is limited to the repair or replacement of instruments.• Repair or replacement is dependent upon return of the instrument to Synthes (USA).• Excluded from this warranty are batteries and all cutting instruments, i.e. drill bits, taps, chisels, fixed-head reamers,

osteotomes, periosteal elevators, and gouges.• This warranty and the undertaking to replace or repair is in exclusion of all other warranties and remedies.

SYNTHES POWER EQUIPMENT WARRANTIESThe Synthes Standard Warranty provides free-of-charge repair of Synthes power equipment for one year from the date ofSynthes invoice. All warranties presume proper use of the equipment under normal operating conditions and in accordancewith the respective Synthes User’s Manual. To ensure optimal performance of your Power Equipment, Synthes offers customersthe opportunity to purchase Extended Warranty and Service Programs (see page 29) in addition to the Synthes StandardWarranty. Drive units, attachments, and accessories, including batteries for the Small Battery Drive, Power Drive and BatteryPower Line systems, are covered by the standard warranty.• Warranty is limited to repair or replacement.• Repair or replacement is dependent upon return to, and inspection of equipment by, Synthes.• The decision to repair or replace the equipment is at the sole discretion of Synthes.• Excluded from the warranty are all power equipment disposable accessories, including drill bits, saw blades, burrs, etc.• The Rechargeable Battery Pack for the Battery Powered Screwdriver has a 60-day warranty from date-of-invoice.• The sterile Single-Use Battery Pack for the Battery Powered Screwdriver has a 30-day warranty from date-of-invoice.• These warranties and the undertaking to replace or repair are in exclusion of all other warranties and remedies.

External Fixation 3–1 thru 3–55

Plates and Screws 1–1 thru 1–442

IM Nails 2–1 thru 2–112

Biomaterials 6–1 thru 6–4

Numerical Index N–1 thru N–11

Alphabetical Index A–1 thru A–5

Cases, Trays and Screw RacksReference Materials

7–1 thru 7–12

General Instrumentsand Implants

5–1 thru 5–73

CONTENTS

Small Joint Arthroplasty 4–1 thru 4–12

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Suggestions Concerning Orthopaedic Metallic Internal Fixation DevicesThe use of metallic surgical implants has given the surgeon a means of bone fixation and helps generally in the management offracture and reconstructive surgery; however, these implants are intended only to assist healing and not intended to replacenormal body structures. Metallic bone fixation devices are internal splints which align the fracture while normal healing occurs.The size and shape of bones and soft tissue place limitations on the size and strength of implants. If there is delayed union ornonunion of bone in the presence of weight bearing or load bearing, the implant could eventually break due to metal fatigue.Therefore, it is important that immobilization of the fracture site be maintained until firm bony union (confirmed by clinical andradiographic examination) is established. All metallic surgical implants are subject to repeated stresses in use, even in the absenceof direct weight bearing, which can result in metal fatigue. Factors such as the patient’s weight, activity level, and adherence toweight bearing or load bearing instructions have an effect on the stresses to which the implant is subjected, and therefore on thelife of the implant. It is important to note that these implants may break at any time if they are subjected to sufficient stresses.

The surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the implant but also must beaware of the mechanical and metallurgical aspects of surgical implants. Postoperative care is extremely important. The patientmust be warned that noncompliance with postoperative instructions could lead to loosening or breakage of the implant, and/orpossibly migration, requiring revisional surgery.

The following are specific warnings, precautions, and adverse effects which must be understood by the surgeon and explained tothe patient. These warnings do not include all adverse effects which could occur with surgery in general, but are importantconsiderations particular to metallic internal fixation devices. General surgical risks should be explained to the patient prior tosurgery.

Warnings1. Correct selection of the implant is extremely important. The potential for success of fracture fixation is increased by the

selection of the proper size, shape and design of the implant. While proper selection can help minimize risks, the size andshape of human bones present limitations on the size and strength of implants. Metallic internal fixation devices cannotwithstand activity levels and/or loads equal to those placed on normal healthy bone, as these devices are not designed towithstand the unsupported stress of full weight bearing or load bearing.

2. These devices can break when subjected to the increased loading associated with delayed union or nonunion.Internal fixation appliances are load sharing devices which hold a fracture in alignment until healing occurs. If healing isdelayed, or does not occur, the implant could eventually break due to metal fatigue. Loads produced by weight bearing andactivity levels will dictate the longevity of the implant. The patient should understand that stress on an implant can involvemore than weight bearing. In the absence of solid bony union, the weight of the limb alone, muscular forces associated withmoving a limb, or repeated stresses of apparent relatively small magnitude, can result in failure of the implant. Notches orscratches put in the implant during the course of surgery may also contribute to breakage.

3. Corrosion. Implanting metals and alloys in the human body subjects them to an aggressive chemical environment of salts,acids, and proteins which can cause corrosion. Dissimilar metals in contact with each other can accelerate the corrosionprocess due to galvanic corrosion effects. Additionally, mixing of implant components from different manufacturers is notrecommended, for metallurgical, mechanical and functional reasons.

4. Certain degenerative diseases or underlying physiological conditions such as diabetes or rheumatoid arthritis may alter thehealing process, thereby increasing the risk of implant breakage.

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Instruments and implants approved by the AO Foundation 8/11

Precautions

1. Surgical implants must never be reused. An explanted metal implant must never be reimplanted. Even though the deviceappears undamaged, it may have small defects and internal stress patterns which could lead to breakage.

2. Correct handling of the implant is extremely important. Contouring of metallic implants should be avoided wherepossible. If contouring is necessary, or allowed by design, the surgeon should avoid sharp bends, reverse bends, or bend ingthe device at a screw hole. The operating surgeon should avoid any notching or scratching of the device when contouringit. These factors may produce internal stresses which may become the focal point for eventual breakage of the implant.

3. Removal after fracture healing. Metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield boneeven after a fracture has healed, particularly in young, active patients. While the surgeon must make the final decision onimplant removal, we recommend that whenever possible and practical for the individual patient, fixation devices should beremoved once their service as an aid to healing is accomplished. Implant removal should be followed by adequate postop -erative management to avoid refracture.

4. Adequately instruct the patient. Postoperative care and the patient’s ability and willingness to follow instructions are twoof the most important aspects of successful fracture healing. This is particularly important should the device be used to treatan unstable fracture, such as intertrochanteric or subtrochanteric. The patient must be made aware of the limitations of theimplant and that physical activity and full weight bearing or load bearing have been implicated in premature loosening,bending or fracture of internal fixation devices. The patient should understand that a metallic implant is not as strong as anormal, healthy bone and will fracture under normal weight bearing or load bearing in the absence of complete bonehealing. Mental or physical impairment which compromises or prevents a patient’s ability to comply with necessary limitationsor precautions may place that patient at a particular risk during postoperative rehabilitation.

Possible Adverse Effects1. Nonunion or delayed union which can lead to

breakage of the implant.2. Metal sensitivity, or allergic reaction to a foreign body.3. Limb shortening due to compression of the fracture

or bone resorption.4. Decrease in bone density.

5. Pain, discomfort, or abnormal sensations due to thepresence of the device.

6. Nerve damage due to surgical trauma.7. Necrosis of bone.8. Vascular changes.

SterilityUnless supplied sterile, metallic internal fixation devices must be sterilized prior to surgical use. Steam sterilization is recom mendedusing the Association for the Advancement of Medical Instrumentation (AAMI) guideline “Good Hospital Practice: SteamSterilization and Sterility Assurance.” The cycle parameters recommended in this standard are suggestions. It is the user’sresponsibility to validate any steam sterilization parameters that are not provided directly by the manufacturer.

Implant UsageThe use of AO surgical implants has given the surgeon a means of stable internal fixation in the management of fractures andreconstructive surgery. However, the surgeon should be fully aware that AO implants are intended for use in internal fixation inaccordance with techniques developed by the AO group. The products should not be used unless the surgeon is thoroughlyfamiliar with the AO method as described in the latest editions of the Manual of Internal Fixation, M. E. Muller, et. al (Springer-Verlag: New York, Heidelberg, Berlin), AO Principles of Fracture Management, T. P. Ruedi and W. M. Murphy (Thieme: Stuttgart,New York), Manual of Internal Fixation in the Cranio-Facial Skeleton, L. A. Assael, et. al (Springer-Verlag: New York, Heidelberg,Berlin), and Small Fragment Set Manual, U. Helm and K. M. Pfeiffer (Springer-Verlag: New York, Heidelberg, Berlin). It is alsorecommended that surgeons utilizing these instruments and implants attend one of the various AO ASIF instructional coursesoffered periodically in North America and around the world.

Additional information regarding specific devices may be obtained from Synthes.

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Information on Synthes Stainless Steel Implants

Synthes implants are produced from implant-quality type 316L stainless steel, which typically contains 62.5% iron, 17.6 %chromium, 14.5% nickel, 2.8 % molybdenum, and minor alloy additions. A low carbon composition is specified to assure thatthe material will be free from susceptibility to intergranular corrosion.

Implant-quality 316L stainless steel meets the metallurgical requirements established by the American Society for Testing andMaterials (ASTM) and the International Organization for Standardization (ISO). The major implant industry standards includeASTM F 138 (bar and wire), ASTM F 139 (sheet and strip), and ISO 5832-1. Implant-quality material must also meet stringentSynthes internal specifications for composition limits, microstructure uniformity, and mechanical properties. All implant-qualitymaterial received from approved suppliers is recertified by Synthes (USA) to provide an extra measure of Quality Assurance thatmetallurgical requirements have been met. Other implantable grades of stainless steel such as 22Cr-13Ni-5Mn have also beenused for specialized applications.

Certain implants, such as cerclage wire or pelvic reconstruction plates, are produced from AO implant-quality 316L stainless steelin the annealed or softest condition. This is needed for applications which demand maximum contourability. The majority of 316Lstainless steel implants are produced from cold work or strengthened material. Some small diameter implants such as K-wire,Steinmann pins, and Schanz screws may be highly cold worked to resist permanent bending deformation. Implant-quality 316Lstainless steel is completely nonmagnetic, regardless of condition.

Synthes instruments and implants are designed and manufactured to maintain optimum system performance. For this reason,316L stainless steel implants produced by other manufacturers should not be mixed with 316L stainless steel implants. The in vivoperformance of a mixed implant system may be compromised as a result of composition differences, strength variations, anddesign or workmanship factors.

The Synthes System offers:

1. Implants and instruments of consistent high quality

2. Implants made of metallurgically uniform and corrosion resistant stainless steel

3. Implants with a good combination of strength and ductility

4. Implants manufactured by methods which do not adversely affect the quality of the raw material

5. Proper fit and dimensional uniformity as a result of precision manufacturing techniques

6. A product reflecting the research efforts of a group of highly trained professionals

Reference:Synthes Implant Materials: Wrought 18% Chromium-14% Nickel-2.5% Molybdenum Stainless Steel

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Instruments and implants approved by the AO Foundation 8/11

Information on Synthes Titanium Implants

Implants made from commercially pure (CP), i.e. unalloyed, titanium have been successfully used in clinical practice by the AOgroup since 1965. Unalloyed titanium has a documented history of outstanding biocompatibility. Clinical experience demonstratesthat tissue adjacent to titanium implants is well vascularized with a reduced tendency toward capsule formation. These biologicallyfavorable conditions may help to reduce the spread of bacteria and increase the resistance to infection.

Unalloyed titanium can be produced using advanced processing methods that significantly increase the strength of the material.Various combinations of strength and ductility are provided to meet the demands of each specific implant application. Titaniumalloys such as Ti-6Al-7Nb and Ti-15Mo are used for a variety of Synthes titanium implants, where increased strength or otherspecialized properties are required.

The majority of titanium implants have a special anodized surface finish that increases the thickness of the protective oxide film.The surface treatment normally creates a colored appearance that distinguishes Synthes titanium implants; however, carefulcontrol of the process can produce a variety of colors, allowing color-coding of implants for easy identification.

Improved biocompatibility, proven functional performance, and excellent corrosion resistance are important advantages of Synthes titanium implants. Additional clinical benefits include the absence of metal allergy reactions, permanent implantationoptions, preservation of the biological environment, and enhanced MRI resolution.

References:Synthes Implant Materials: Unalloyed TitaniumSynthes Implant Materials: Titanium-6% Aluminum-7% NiobiumSynthes Implant Materials: Wrought Titanium-15% Molybdenum

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Printed in U.S.A. 5/11 J4200-C

Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380Telephone: (610) 719-5000To order: (800) 523-0322Fax: (610) 251-9056

© 2011 Synthes, Inc. or its affiliates. All rights reserved.

www.synthes.com