OLIVE WIRE THREADED 1.4MM

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN - EVENT OCCURRED IN SOUTH AFRICA. VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED BOTH WIRES ARE BROKEN. MEDICAL RECORDS WERE NOT PROVIDED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT IS CONFIRMED. 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.

Description of Event or Problem

IT WAS REPORTED THE SURGEON WAS REMOVING A THREADED OLIVE WIRE FROM THE PLATE. AS THE WIRE WAS BEING REVERSED OUT, IT BROKE AT THE SHAFT. ANOTHER WIRE WAS THEN USED AND BROKE IN THE SAME MANNER. BOTH BROKEN TIPS REMAIN IMPLANTED WITHIN THE PATIENT SINCE THEY WERE IMBEDDED AND UNABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETED BY USING A SHORT LOCKING SCREW TO INSERT WHERE THE WIRES BROKE OFF. DELAY OF SURGERY WAS LESS THAN 30 MINUTES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.