BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME II HANDPIECE

    MDR report key: 3250328 · Received July 24, 2013

    Report

    Report Number
    1526350-2013-00396
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 04/17/2013 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. EVALUATION OF THE DEVICE DETERMINED THAT THE MOTOR DID NOT RUN, BUT AIR PASSED THROUGH THE DEVICE AND BACK INTO THE HOSE RETURNED BY THE CUSTOMER. PRIOR TO REPAIR, THE DEVICE WAS WITHIN CALIBRATION SPECIFICATIONS AT ALL SETTINGS. IT WAS ALSO OBSERVED THAT THE PLANETARY GEAR WAS FROZEN ONTO THE DOWEL PIN OF THE PLANETARY GEAR CARRIER AND THE THREE GEARS BACK ONTO THE PLANETARY CARRIER AND OBSERVE IF THE GEARS ROTATED TOGETHER, THE GEAR PLACED UPON THE GALLED DOWEL PIN BECAME STUCK. UPON REMOVAL OF THE GEAR FROM THE DOWEL PIN, THE INSIDE OF THE GEAR WAS DAMAGED, AND DID NOT PASS THE INTERIOR DIAMETER SPECIFICATIONS. THE CAUSE OF THE REPORTED EVENT WAS MOST LIKELY DUE TO DAMAGE OF THE DOWEL PIN WHICH WOULD NOT ALLOW THE PLANETARY GEARS TO ROTATE FREELY. THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME II WOULD NOT TURN ON AND WAS MAKING A HISSING NOISE. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE DEVICE QUIT WORKING MIDWAY THROUGH HARVESTING A SKIN GRAFT. IT WAS REPORTED THAT THE HARVESTED GRAFT TISSUE LOOKED FINE. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION AND NO ADDITIONAL UNPLANNED GRAFT HARVEST REQUIRED AS A RESULT OF THE REPORTED ISSUE. AN ADDITIONAL DEVICE WAS AVAILABLE ONSITE TO COMPLETE THE PROCEDURE AND THERE WAS NO EXTENSION IN SURGICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346863 ZIMMER AIR DERMATOME II HANDPIECE ZIMMER AIR DERMATOME II HANDPIECE FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1