K-WR SGL END TRCR TIP SMTH 1.6X150MM

Description of Event or Problem

IT WAS REPORTED THAT DURING DRILLING OF THE FIRST SCREW A K-WIRE BROKE. A 2ND K-WIRE WAS THEN USED WHICH ALSO BROKE DURING DRILLING AND REMAINED STUCK IN THE DRILL. THE CASE WAS COMPLETED, AND THE K-WIRE FOREIGN BODIES WERE RETAINED WITHIN THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). D10: P99-192-1615, LOT: UNKNOWN, K-WR SGL END TRCR TIP SMTH 1.6X150MM. P99-110-3516, LOT: OR2210013, DRILL 3.5X160MM CAN 3/16IN SQ. G2: FOREIGN- EVENT OCCURRED IN UNITED KINGDOM. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER INVOLVED IN THIS EVENT IS UNKNOWN. COMPLAINT SAMPLE WAS EVALUATED, AND THE REPORTED EVENT WAS CONFIRMED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.