HANDPIECE, ELECTRIC DERMATOME

Additional Manufacturer Narrative

THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2: FOREIGN - EVENT OCCURRED IN SOUTH AFRICA REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE DEVICE WOULD NOT STAY ON, THE RECIPROCATING ARM, E-RING, AND SCREW WERE WORN, AND A SCREW WAS MISSING. THE MOTOR, RECIPROCATING ARM, E-RING, AND SCREWS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. ABLE TO CONFIRM REPORTED EVENT. 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.

Description of Event or Problem

IT WAS REPORTED THAT OUTSIDE OF SURGERY THE DEVICE WAS SENT FOR SERVICE. DURING INVESTIGATION WAS FOUND THAT DEVICE DOES NOT STAY ON AND PARTS WERE MISSING. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.