BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME KIT

    MDR report key: 2181271 · Received July 8, 2011

    Report

    Report Number
    1526350-2011-00141
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR. THE SVC RECORDS INDICATE THAT THE DEVICE IS 10 YEARS OLD AND HAS BEEN RETURNED FOR REPAIR PREVIOUSLY. THE INSPECTION FOUND THAT THE DEVICE WAS RECEIVED WITH NORMAL WEAR AND TEAR. THE MOTOR RAN SMOOTHLY, AND THE DEVICE APPEARED TO OPERATE NORMALLY WITH ALL CALIBRATIONS WITHIN SPEC. THE CAUSE OF THE REPORTED ISSUE IS UNKNOWN. THE CORRECT MOTOR SPEED AND THICKNESS LEVER SETTINGS PLAY A MAJOR PART IN ATTAINING THE SUCCESSFUL GRAFT THICKNESS SELECTED. BOTH OF THESE SETTINGS, AS WELL AS ALL OTHER CALIBRATIONS, WERE WITHIN SPECS. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME WAS CUTTING THE SKIN TOO THICK. ADDITIONAL CLINICAL F/U WITH THE HOSPITAL INDICATED THAT THE GRAFT WAS USABLE AND NO ADDITIONAL DONOR GRAFT WAS REQUIRED. AN AVAILABLE ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ADDITIONAL INTERVENTION, DELAY, OR INCREASED SURGICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR DERMATOME KIT AIR DERMATOME KIT GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1