DRILL BIT D 4MM - L 310 MM

Additional Manufacturer Narrative

WHILE THIS EVENT DOES NOT MEET THE FDA REQUIREMENTS OF MANDATORY REPORTING, AFTER SPEAKING WITH FDA AND IN KEEPING WITH THE INDICATIONS PROVIDED IN THE "PUBLIC HEALTH NOTIFICATION: UNRETRIEVED DEVICE FRAGMENTS" ISSUED ON JANUARY 15, 2008, ORTHOFIX SRL HAS DECIDED TO REPORT THIS TYPE OF EVENT ON A VOLUNTARY BASE. THE DEVICE WAS SUBJECTED TO CHEMICAL, MECHANICAL, METALLURGICAL AND FAILURE ANALYSES. TECHNICAL ANALYSIS PERFORMED ON THE DEVICE SHOWED IT TO BE COMPLIANT WITH ORTHOFIX PRODUCT SPECIFICATIONS. THE METALLOGRAPHIC EXAMINATION OF THE FRACTURE SURFACE OF THE DEVICE SHOWED A BRITTLE FRACTURE WITH INTERGRANULAR MECHANISM. IN AS MUCH AS NO ADD'L INFO HAS BEEN PROVIDED ABOUT THE CIRCUMSTANCES OF THE SPECIFIC APPLICATION, IT IS NOT POSSIBLE TO CONDUCT A ROOT CAUSE ANALYSIS AT THIS TIME. THE ONLY ASSUMPTION THAT COULD BE MADE IS THAT IT IS LIKELY THE DRILL BIT WAS SUBJECTED TO REPEATED BENDING LOADS DURING INSERTION WHICH CAUSED IT TO BREAK. ORTHOFIX WILL MONITOR SIMILAR PRODUCTS ON THE MARKET AND REPORT ADD'L INFO ABOUT THIS INCIDENT SHOULD IT BECOME AVAILABLE.

Description of Event or Problem

THE DRILL BIT BROKE DURING APPLICATION IN SURGERY FOR A FRACTURED FEMUR PERFORMED ON (B) (6) 2007. THE EVENT WAS ONLY REPORTED TO THE MFR IN (B) (6) OF 2008. AS WAS CONFIRMED BY PT X-RAYS AND REPORTED TO ORTHOFIX, THE DISTAL PORTION OF THE BROKEN DEVICE REMAINS IN THE FEMUR, BUT IT HAS NOT HAD ANY ADVERSE EFFECT ON THE PT'S HEALING PROGRESS.