BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3394839 · Received September 19, 2013

    Report

    Report Number
    1526350-2013-00519
    Event Type
    Malfunction
    Date Received
    September 19, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 22, 2013
    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 09/18/1989 AND WAS LAST REPAIRED ON 04/06/2013 FOR PREVENTATIVE MAINTENANCE. EVALUATION OF THE DEVICE OBSERVED CUTS TO THE AIR HOSE. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATION AT THE ZERO THICKNESS SETTING ON THE LEFT SIDE. THE DEVICE PASSED SIDE TO SIDE CALIBRATION AT ALL THICKNESS SETTINGS. UNABLE TO DETERMINE A CAUSE OF THE REPORTED COMPLAINT; HOWEVER, IMPROPER HANDLING LIKELY CAUSED THE DAMAGE TO THE HOSE AND LACK OF CALIBRATION AT THE ZERO THICKNESS SETTING. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUTTING SURFACE OF THE ZIMMER AIR DERMATOME WAS AN UNEVEN DEPTH, AND DOES NOT ADJUST EVENLY ON BOTH SIDES. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL CLINICAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473009 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1