BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3752933 · Received February 5, 2014

    Report

    Report Number
    1526350-2014-00067
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 8, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 03/19/1991 AND WAS LAST REPAIRED ON (B)(6) 2013 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED THE DEVICE TO BE OUTSIDE CALIBRATION SPECIFICATIONS ONLY AT THE ZERO THICKNESS SETTING ON THE LEFT AND RIGHT SIDE, AND THE SIDE TO SIDE. THE DEVICE WAS WITHIN CALIBRATION SPECIFICATIONS AT ALL OTHER TESTED THICKNESS SETTINGS. NO VISIBLE ISSUES WERE OBSERVED WITH DEVICE. THE MASTER BLADE WAS FLUSH WITH THE CONTROL BAR AND THE DEVICE OPERATED WITHIN MOTOR SPEED SPECIFICATION. REPAIR OF THE UNIT WAS NOT PERFORMED, AS THE CUSTOMER REQUESTED THE DEVICE BE RETURNED WITHOUT BEING SERVICED. WHILE THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS AT THE ZERO THICKNESS SETTING, THE DEVIATION FROM SPECIFICATION WAS MINOR AND CUTTING IS NOT PERFORMED AT THE ZERO THICKNESS. A CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. NO INFORMATION IS KNOWN REGARDING THE TECHNIQUE OR METHODS UTILIZED BY THE USER DURING THE REPORTED EVENT; HOWEVER, APPLYING TOO MUCH OR TOO LITTLE DOWNWARD PRESSURE WHILE TAKING THE GRAFT CAN CAUSE THE DERMATOME TO TAKE A GRAFT WHICH DEVIATES FROM THE DESIRED THICKNESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN USING THE ZIMMER AIR DERMATOME, THE DEPTH OF THE GRAFT WAS NOT WHAT THE SURGEON EXPECTED. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75298 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1