InterPhlex. Flexible Stabilization Rods. Surgical Technique Guide
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1 InterPhlex Flexible Stabilization Rods Surgical Technique Guide
2 DANGER indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. WARNING indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION indicates a potentially hazardous situation which, if not avoided, could result in minor or moderate injury. CAUTION used without the safety alert symbol indicates a potentially hazardous situation which, if not avoided, may result in property damage.
3 Instructions for Use Osteomed INTERPHALANGEAL Flexible Stabilization Rods 1. A straight longitudinal or short curvilinear skin incision is made over the dorsum of the interphalangeal joint. 2. Retract the skin bilaterally and deepen the wound to the extensor expansion. 3. The extensor tendon is incised and reflected. Dorsal veins should be carefully retracted. 4. A longitudinal capsulotomy is performed, exposing the interphalangeal joint. 5. The interphalangeal joint is excised. To ensure proper implant fit, only the drill included in the sterile surgical set should be used to implant the device. Do not use drill or sizers if sterile package is damaged. 6. The drill included in the sterile surgical pack is used to prepare the medullary canals for implant placement. Note: Laser marking on drill flutes is in 5mm increments. 7. The sizers are used to determine the correct size and final fit of each implant. The size of the implant depends on amount of bone resected and size of the patient. The implant can be further modified by trimming the stems if necessary. 8. Thoroughly irrigate the wound for final implant placement. Do not use implant if sterile package is damaged. 9. Place the implant. 10. Flush the implant site with copious irrigation. 11. Reattach the capsule of the interphalangeal joint, suture the extensor tendon, close the subcutaneous tissue, and close the skin. Recommendations for implant handling: 1. Contact with gowns, drapes, gloves, sponges, or any other possible source of foreign body contaminants should be avoided. 2. Excessive handing of the implant should be avoided. 3. The implant should be handled with a blunt instrument. 4. The implant should be kept immersed in sterile antibiotic solution after the introduction to the operative field. 5. After trimming, rinse the implant thoroughly to remove any free particles. 1
4 Instructions for Use Osteomed METATARSOPHALANGEAL Flexible Stabilization Rods 1. A straight longitudinal or short curvilinear skin incision is made over the dorsum of the metatarsophalangeal joint. 2. Retract the skin bilaterally and deepen the wound to the extensor expansion. 3. Dorsal veins and extensor tendon should be carefully retracted. 4. A longitudinal capsulotomy is performed, exposing the metatarsophalangeal joint. 5. The metatarsophalangeal joint is excised. To ensure proper implant fit, only the drill included in the sterile surgical set should be used to implant the device. Do not use drill or sizers if sterile package is damaged. 6. The drill included in the sterile surgical pack is used to prepare the medullary canals for implant placement. Note: Laser marking on drill flutes is in 10mm increments. 7. The sizers are used to determine the correct size and final fit of each implant. The size of the implant depends on amount of bone resected and size of the patient. The implant can be further modified by trimming the stems if necessary. 8. Thoroughly irrigate the wound for final implant placement. Do not use implant if sterile package is damaged. 9. Place the implant. 10. Flush the implant site with copious irrigation. 11. Reattach the capsule of the metatarsophalangeal joint, close the subcutaneous tissue, and close the skin. Recommendations for implant handling: 1. Contact with gowns, drapes, gloves, sponges, or any other possible source of foreign body contaminants should be avoided. 2. Excessive handing of the implant should be avoided. 3. The implant should be handled with a blunt instrument. 4. The implant should be kept immersed in sterile antibiotic solution after the introduction to the operative field. 5. After trimming, rinse the implant thoroughly to remove any free particles. 2
5 System Components Inter-Phlanageal Sterile Surgical Kit (Drills and Trials) Metatarsal Phlanageal Sterile Surgical Kit (Drills and Trials) Inter-Phalangeal Flexible Stabilization Rod, 4.0mm Inter-Phalangeal Flexible Stabilization Rod, 4.5mm Metatarsal Phalangeal Flexible Stabilization Rod, 8mm Metatarsal Phalangeal Flexible Stabilization Rod, 10mm 3
6 Osteomed L.P. Customer Service: Tel: Fax: Arapaho Road, Addison, Texas P/N Rev. D
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