2.0X7MM BONE REDUCTION BLADE

Description of Event or Problem

NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D1, D2, D4, H4 THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G6, H2, H3, H6, H10 QUANTITY OF ONE 2.0X7MM BONE REDUCTION BLADE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION IDENTIFIED THE TIP TO BE FRACTURED. THE PART AND LOT INFORMATION WERE VERIFIED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Additional Manufacturer Narrative

ZIMMER BIOMET COMPLAINT (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE: (B)(4).

Description of Event or Problem

IT WAS REPORTED THE SCREW TIP BROKE DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF A ZYGOMATIC FRACTURE. THE SCREW TIP REMAINED IN THE BODY WITHOUT REDUCTION. THE BONE WAS SCRAPED AND THE SCREW TIP FRAGMENT WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION WAS AVAILABLE.