Instructions for Use
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Instructions for Use - Warnings and Precautions Speed™ I. General The Speed™ Nitinol Implant System gives the surgeon a means of bone fixation and helps in the management of fracture and reconstructive surgery. II. Basic Structure • The implants of the Speed™ Fixation System are made of biocompatible Nitinol and are designed to exhibit superelastic properties at room temperature. Each implant is constrained in an open shape during storage and insertion. Once inserted, release from the constraining device causes the implant’s legs to deflect toward each other resulting in compression. In good bone quality, this deflection may not be visible as the legs are constrained by the surrounding tissue. • BME offers several different types of implants. The implant model number designates its dimensions. EXAMPLE: SE-1310 has a 13mm bridge length and 10mm leg length. III. Indications For Use • Small bone fragment adjunctive fixation. • Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. IV. Contraindications • Comminuted bone surface that would militate against staple placement. • Pathologic conditions of bone such as osteopenia that would impair the ability to securely fix the implant. • Foreign body sensitivity to metals including nickel. Where material sensitivity is suspected, appropriate tests should be made prior to implantation.
V. Warnings • The implants cannot be expected to replace normal healthy bone or withstand the stress placed upon the device by full or partial weight bearing or load bearing in the presence of nonunion, delayed union or incomplete healing. Therefore, it is important that immobilization of the treatment site using routine methods (casting, splints, etc.) be maintained until bone healing has occurred (4-6 weeks). • Reduction of the site should be achieved and maintained prior to implanting the device. The compressive force of the staple closing should not be relied upon to achieve closure or reduction of a fracture line. • The Speed™ Nitinol Implant System has not been evaluated for safety and compatibility in the MR environment. The device has not been tested for heating or migration in the MR environment. • Any additional processing or reprocessing of the implant may affect the shape memory properties of the nitinol, changing or otherwise reducing the effectiveness of the implant. • Drill bits are designed for use specifically with the BME supplied drill guides. Reprocessing may affect the compatibility with other instruments and usability of the instruments. VI. Clinical Use Examples • Hand Surgery: Intracarpal arthrodesis, radiocarpal arthrodesis, carpometacarpal arthrodesis, metacarpophalangeal arthrodesis, and interphalangeal arthrodesis. Additional uses include carpal, metacarpal and phalangeal fracture and osteotomy fixation. • Foot Surgery: Interphalangeal arthrodesis, metatasophalangeal arthrodesis, Hallux Valgus correction, midfoot arthrodesis and hindfoot arthrodesis. Additional uses include tarsal, metatarsal and phalangeal fracture and osteotomy fixation.
Instructions for Use - Warnings and Precautions Speed™ I. General The Speed™ Nitinol Implant System gives the surgeon a means of bone fixation and helps in the management of fracture and reconstructive surgery. II. Basic Structure • The implants of the Speed™ Fixation System are made of biocompatible Nitinol and are designed to exhibit superelastic properties at room temperature. Each implant is constrained in an open shape during storage and insertion. Once inserted, release from the constraining device causes the implant’s legs to deflect toward each other resulting in compression. In good bone quality, this deflection may not be visible as the legs are constrained by the surrounding tissue. • BME offers several different types of implants. The implant model number designates its dimensions. EXAMPLE: SE-1310 has a 13mm bridge length and 10mm leg length. III. Indications For Use • Small bone fragment adjunctive fixation. • Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. IV. Contraindications • Comminuted bone surface that would militate against staple placement. • Pathologic conditions of bone such as osteopenia that would impair the ability to securely fix the implant. • Foreign body sensitivity to metals including nickel. Where material sensitivity is suspected, appropriate tests should be made prior to implantation.
V. Warnings • The implants cannot be expected to replace normal healthy bone or withstand the stress placed upon the device by full or partial weight bearing or load bearing in the presence of nonunion, delayed union or incomplete healing. Therefore, it is important that immobilization of the treatment site using routine methods (casting, splints, etc.) be maintained until bone healing has occurred (4-6 weeks). • Reduction of the site should be achieved and maintained prior to implanting the device. The compressive force of the staple closing should not be relied upon to achieve closure or reduction of a fracture line. • The Speed™ Nitinol Implant System has not been evaluated for safety and compatibility in the MR environment. The device has not been tested for heating or migration in the MR environment. • Any additional processing or reprocessing of the implant may affect the shape memory properties of the nitinol, changing or otherwise reducing the effectiveness of the implant. • Drill bits are designed for use specifically with the BME supplied drill guides. Reprocessing may affect the compatibility with other instruments and usability of the instruments. VI. Clinical Use Examples • Hand Surgery: Intracarpal arthrodesis, radiocarpal arthrodesis, carpometacarpal arthrodesis, metacarpophalangeal arthrodesis, and interphalangeal arthrodesis. Additional uses include carpal, metacarpal and phalangeal fracture and osteotomy fixation. • Foot Surgery: Interphalangeal arthrodesis, metatasophalangeal arthrodesis, Hallux Valgus correction, midfoot arthrodesis and hindfoot arthrodesis. Additional uses include tarsal, metatarsal and phalangeal fracture and osteotomy fixation.
VII. Instructions 1. Determine the correct implant size by using the BME Speed™ X-Ray Template or intraoperatively using the BME Continuous Compression Implant Sizing Guide to measure the fusion site. 2. Open the chosen Implant Kit and its corresponding Drill Bit Kit. Connect the Drill Guide Tip, located in the Implant Kit, to the Drill Guide Handle located in the Drill Bit Kit. 3. While ensuring full reduction, place the Drill Guide Assembly across the fusion site with both prongs touching bone. Drill the first hole using the Drill Bit provided in the Drill Bit Kit until the positive stop is felt. 4. Insert a Locator Pin into the first hole and, while ensuring full reduction, repeat step three to create the second hole. 5. Insert another Locator Pin into the second hole. The Drill Guide Assembly can be removed, leaving the Locator Pins in place to mark the position of the drill holes. 6. Remove the Storage/Insertion Stick containing the Speed™ implant from the Implant Package. Remove the Locator Pins from the predrilled holes and align the tips of the legs of the Speed™ Implant parallel with the drill holes. 7. Insert the Speed™ implant as far as possible into the predrilled holes. Note: To ensure proper implant placement, fluoroscopy may be used prior to releasing the implant. 8. Twist the Storage/Insertion Stick to release the implant. The Stick can be twisted in either direction. 9. Align the supplied Tamp with the bridge of the implant and use as needed to completely seat the implant.
Manufactured by: BioMedical Enterprises, Inc. 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245 Phone (210) 677-0354 Fax (210) 677-0355 Toll Free (800) 880-6528
VIII. Removal 1. Expose the site and the bridge of the implant. 2. Using forceps grasp the center of the implant and remove. If the implant is recessed, then use an elevator to lift the implant bridge and then use forceps to remove the implant. If the implant is solidly connected, cut the bridge with wire cutters and twist and remove each staple leg. IX. Care and Caution • Non-sterile ancillary equipment should be sterilized by a gravity feed autoclave cycle at 121°C (250°F) for 30 minutes. Alternatively, a pre-vac autoclave cycle of 135°C (275°F) for 4 minutes is acceptable. A drying cycle of 15 minutes is recommended. These recommended cycle times presuppose properly maintained autoclave equipment used with due diligence by the operator. Inspect each item prior to use. Do not use if there is any indication of cracks or crazing. • Inspect the sterile packaging used for the implants or instruments prior to use. Sterilization cannot be assured and implant should not be used if packaging or seal is damaged. Speed™ implants may be stored at room temperature.
0434 A120-001 Rev. 4
VII. Instructions 1. Determine the correct implant size by using the BME Speed™ X-Ray Template or intraoperatively using the BME Continuous Compression Implant Sizing Guide to measure the fusion site. 2. Open the chosen Implant Kit and its corresponding Drill Bit Kit. Connect the Drill Guide Tip, located in the Implant Kit, to the Drill Guide Handle located in the Drill Bit Kit. 3. While ensuring full reduction, place the Drill Guide Assembly across the fusion site with both prongs touching bone. Drill the first hole using the Drill Bit provided in the Drill Bit Kit until the positive stop is felt. 4. Insert a Locator Pin into the first hole and, while ensuring full reduction, repeat step three to create the second hole. 5. Insert another Locator Pin into the second hole. The Drill Guide Assembly can be removed, leaving the Locator Pins in place to mark the position of the drill holes. 6. Remove the Storage/Insertion Stick containing the Speed™ implant from the Implant Package. Remove the Locator Pins from the predrilled holes and align the tips of the legs of the Speed™ Implant parallel with the drill holes. 7. Insert the Speed™ implant as far as possible into the predrilled holes. Note: To ensure proper implant placement, fluoroscopy may be used prior to releasing the implant. 8. Twist the Storage/Insertion Stick to release the implant. The Stick can be twisted in either direction. 9. Align the supplied Tamp with the bridge of the implant and use as needed to completely seat the implant.
Manufactured by: BioMedical Enterprises, Inc. 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245 Phone (210) 677-0354 Fax (210) 677-0355 Toll Free (800) 880-6528
10. Repeat steps 1-9 for each additional implant used. Tip: If implants are placed at 90-degrees to each other, stagger them to ensure unobstructed insertion. If a second implant is placed with the bridge in close proximity to another, insert the implant with the open side facing the first implant. This will allow the Stick to be twisted without obstruction.
10. Repeat steps 1-9 for each additional implant used. Tip: If implants are placed at 90-degrees to each other, stagger them to ensure unobstructed insertion. If a second implant is placed with the bridge in close proximity to another, insert the implant with the open side facing the first implant. This will allow the Stick to be twisted without obstruction. VIII. Removal 1. Expose the site and the bridge of the implant. 2. Using forceps grasp the center of the implant and remove. If the implant is recessed, then use an elevator to lift the implant bridge and then use forceps to remove the implant. If the implant is solidly connected, cut the bridge with wire cutters and twist and remove each staple leg. IX. Care and Caution • Non-sterile ancillary equipment should be sterilized by a gravity feed autoclave cycle at 121°C (250°F) for 30 minutes. Alternatively, a pre-vac autoclave cycle of 135°C (275°F) for 4 minutes is acceptable. A drying cycle of 15 minutes is recommended. These recommended cycle times presuppose properly maintained autoclave equipment used with due diligence by the operator. Inspect each item prior to use. Do not use if there is any indication of cracks or crazing. • Inspect the sterile packaging used for the implants or instruments prior to use. Sterilization cannot be assured and implant should not be used if packaging or seal is damaged. Speed™ implants may be stored at room temperature.
0434 A120-001 Rev. 4
European Representative: Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel: (31) (0) 70 345-8570 Fax: (31) (0) 70 346-7299
European Representative: Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel: (31) (0) 70 345-8570 Fax: (31) (0) 70 346-7299