ZIMMER AIR DERMATOME

Additional Manufacturer Narrative

THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE MOTOR SPEEDS WERE UNSTABLE, THE MACHINED HEAD WAS DAMAGED, THE SCREWS WERE WORN, THE SWIVEL WAS LOOSE, THE BALL PLUNGER WAS MISSING FROM THE LEVER, THE E-RING, RECIPROCATING ARM, BEARINGS, NECKPIECE WERE CORRODED, THE CONTROL BAR WAS OUT OF POSITION, AND THE DEVICE WAS OUT OF CALIBRATION. THE MOTOR, SLEEVE, SWIVEL, RECIPROCATING ARM, E-RING, BEARINGS, NECKPIECE, MACHINED HEAD, PIN, BALL PLUNGER, LEVER, SCREWS, AND CONTROL BAR WERE REPLACED, AND THE DEVICE WAS RECALIBRATED TO RESOLVE THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO COMPONENT FAILURE AS THE DEVICE EXHIBITS WEAR AND TEAR FROM REPEATED USE. THE EVENT IS CONFIRMED. 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. G2: FOREIGN - EVENT OCCURRED IN FRANCE.

Description of Event or Problem

IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT HAD CORRODED PARTS, LOOSENING, DAMAGED AND CONTAMINATED. INCONSISTENT SPEED WAS CONFIRMED AFTER FINAL INVESTIGATION. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE.