RECON DRILL BIT
Received May 2, 2008 · Event occurred Mar 5, 2008
Report 9680825-2008-00004 · MDR key 1038835
Device
Generic name
Recon Drill Bit
Manufacturer
Orthofix SrlModel number
173283Catalog number
173283
Lot number
010316
Product problems
- Break
- Device, or device fragments remain in patient
Patient
Not reported
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
DURING SURGERY, THE DISTAL PORTION OF THE DRILL BIT BROKE AND REMAINS IN THE FEMORAL NECK OF THE PT.
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 NOTIFICATIONS: UNRETRIEVED DEVICE FRAGMENTS" ISSUED ON JAN 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 ANALYSIS. TECHNICAL ANALYSIS PERFORMED ON THE DEVICE SHOWED NO ANOMALIES THAT COULD HAVE CONTRIBUTED TO ITS FAILURE. THE METALLOGRAPHIC EXAMINATION OF THE FRACTURE SURFACE OF THE DEVICE SHOWED A BRITTLE FRACTURE WITH INTERGRANULAR MECHANISM CAUSED BY OVERLOAD. INASMUCH AS NO ADD'L INFO HAS BEEN PROVIDED BY THE HOSPITAL ABOUT THE CIRCUMSTANCES OF THE SPECIFIC APPLICATION, IT IS NOT POSSIBLE TO CONDUCT A ROOT CAUSE ANALYSIS AT THIS TIME. ORTHOFIX WILL MONITOR SIMILAR PRODUCTS ON THE MARKET AND REPORT ADD'L INFO ABOUT THIS INCIDENT SHOULD IT BECOME AVAILABLE.