ZIMMER AIR DERMATOME

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN - EVENT OCCURRED IN UNITED KINGDOM. E1: TELEPHONE - (B)(6). COMPLAINT CAN BE CONFIRMED THROUGH THE RETURNED PRODUCT ANALYSIS. REVIEW OF THE MOST RECENT REPAIR RECORD IDENTIFIED THE FOLLOWING RELATED REPAIR: THE UNIT HAD BURNS TEATHER HANDPIECE NOT WORKING. DURING INSPECTION FOUND WORN COMPONENTS, DAMAGED MACHINED HEAD, CORROSION, LOOSE SWIVEL, MOTOR SPEED UNSTABLE, DAMAGED WIDTH PLATE AND DAMAGED STABILIZABLE TRAY. THE RECIPROCATING ARM, SWIVEL, MOTOR, SLEEVE, SCREW, MACHINED HEAD, NECKPIECE, RETAINING RING AND SPRING WERE REPLACED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 DURING AN UNKNOWN TIME, ON AN UNKNOWN DATE, THE UNIT WAS IN NEED OF REPAIR AS THE HANDPIECE DID NOT WORK WHEN PLUGGED INTO AN AIR SUPPLY. UPON DEVICE EVALUATION IT WAS NOTED THAT SPEED WAS INCONSISTENT AND WIDTHPLATE WAS DAMAGED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION.