ZNN¿¢, CMN LAG SCREW REAMER, SHORT

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: THE INSTRUMENT WAS RETURNED FOR INVESTIGATION. THE EVENT CAN BE CONFIRMED AS THE LAG SCREW REAMER IS FRACTURED IN THE CUTTING AREA. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND THE PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT 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.

Description of Event or Problem

DILIGENCE IS COMPLETE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED, THAT DURING A PRIMARY SURGERY APPROXIMATELY ONE MONTH AGO. LAG SCREW REAMER WAS BROKEN, AND SMALL PIECE WAS LEFT INSIDE THE PATIENT. SURGICAL TECHNIQUE WAS FOLLOWED, AND THIS INSTRUMENT WAS USED MANY TIMES BEFORE. ATTEMPTS HAVE BEEN MADE. AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

(B)(4). G2: REPORT SOURCE: SOUTH AFRICA. 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.