K-WR SGL END TRCR TIP SMTH 2.0X150MM

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE A CANNULATED DRIVER TIP BROKE WHEN THE SCREW WAS FULLY SEATED WITH A PLATE. A K-WIRE TIP ALSO BROKE WHEN IT WAS NICKED WITH A DRILL. THE DRIVER TIP DEBRIS WAS RETRIEVED FROM THE PATIENT WITH NO DELAY. THE K- WIRE DEBRIS REMAINS IMPLANTED WITHIN THE PATIENT. THE CASE WAS SUCCESSFULLY COMPLETED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). D10: PART P99-190-TT10, LOT: TC29667, SCW DRIVER ATTCH CAN AO TX-10 UNKNOWN DRILL, PART & LOT: UNKNOWN. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED ON THE WIRE AS THE PART AND LOT NUMBER INVOLVED IN THIS EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.