PICCOLO COMPOSITE PROXIMAL FEMUR NAILING SYSTEM (NAIL)

Additional Manufacturer Narrative

EXAMINATION OF THE PRODUCTION RECORDS OF THE INVOLVED NAIL DID NOT REVEAL ANY DEVIATION FROM SPECIFICATION. THE EXPLANTED NAIL WAS RECEIVED BY THE COMPANY AND EXAMINED. THE NAIL HAS A FRACTURE IN THE UPPER THIRD PORTION OF THE SHAFT. OTHER THAN THAT, THE SURFACE AREA OF THE NAIL LOOKS INTACT IN MACROSCOPIC AND MICROSCOPIC EVALUATION. BIOMECHANICAL TESTING OF THE DISTAL PORTION OF THE RETURNED NAIL WAS PERFORMED. THE TEST WAS SUCCESSFULLY COMPLETED WITH THE PRODUCT COMPLYING WITH THE REQUIREMENTS. BASED ON DATA REPORTED TO THE COMPANY, DURING INSERTION OF THE NAIL INTO THE BONE (HIGHLY DENSE BONE) THE SURGEON HAD TO ROTATE THE NAIL, AND A NOISE WAS HEARD. THIS MIGHT HAVE BEEN THE FORMATION OF A CRACK, THAT MIGHT HAVE CONTRIBUTED TO NAIL FRACTURE. IT IS NOTED THAT IN THE WARNINGS AND PRECAUTIONS SECTION OF THE SYSTEM INSTRUCTIONS FOR USE IT IS INDICATED THAT: "THE SURGEON SHOULD BE CAUTIOUS WITH LIMB POSITION CHANGING AND/OR EXCESSIVE FORCE EXERTION WHILE ACCESSORIES ARE STILL CONNECTED TO THE IMPLANTS, IN ORDER TO AVOID TISSUE AND/OR DEVICE DAMAGE".

Description of Event or Problem

THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO TRAUMA FRACTURE. A PICCOLO COMPOSITE PROXIMAL FEMUR NAIL WAS IMPLANTED. ABOUT 2 WEEKS POST-OPERATION THE PATIENT WAS WALKING AFTER PHYSIOTHERAPY, AND HAD PAIN. X-RAYS REVEALED A FRACTURE IN THE NAIL SHAFT. THE NAIL WAS EXPLANTED AND REPLACED WITH A TITANIUM NAIL.