ZIMMER AIR DERMATOME

Additional Manufacturer Narrative

THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2: FOREIGN - EVENT OCCURRED IN CANADA. D10: CATALOG NUMBER #UNK, WIDTH PLATE; LOT #UNK, SERIAL #UNK. CATALOG NUMBER #UNK, SCREWDRIVER; LOT #UNK, SERIAL #UNK. CATALOG NUMBER #UNK, HOSE; LOT #UNK, SERIAL #UNK. REVIEW OF THE MOST RECENT REPAIR RECORD IDENTIFIED THE FOLLOWING RELATED REPAIR: THE DEVICE WAS NOT WORKING WITH PLATES, SCREWDRIVER, AND HOSE. THE DEVICE COULD NOT GET RPMS DUE TO LEAK IN HOSE, CONTROL BAR WAS LOOSE, AND CALIBRATION READINGS WERE ALL OUT OF SPECIFICATION. ALL WIDTH PLATES, HOSE, SWIVEL, MOTOR, PLANETARY GEAR, LEVER, BALL PLUNGER, SLEEVE BEARING, RECIPROCATING ARM, E-RING, NEEDLE BEARING, BALL BEARING, SPRING SEAL, GASKET, SLEEVE, AND SCREWS 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. 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 BEFORE SURGERY DURING INSPECTION ON AN UNKNOWN DATE, THE DEVICE IS NOT WORKING. INVESTIGATION RESULTS INDICATE THAT LEAKING AIR AND HAD INCONSISTENT SPEED. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.