BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3087032 · Received April 26, 2013

    Report

    Report Number
    1526350-2013-00216
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    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 12/02/1988 AND WAS LAST REPAIRED ON (B)(4) 2012. EVALUATION OF THE DEVICE DETERMINED THAT THE THROTTLE LEVER WAS BROKEN AND THE HEAD WAS DENTED. IT WAS ALSO OBSERVED THAT THE HOSE RETURNED WITH THE DEVICE WAS NOT A ZIMMER HOSE. PRIOR TO REPAIR, THE DEVICE WAS WITHIN CALIBRATION SPECIFICATIONS AT ALL SETTINGS AND THE MOTOR RAN WITHIN SPECIFICATIONS. THE CAUSE OF THE REPORTED EVENT IS MOST LIKELY DUE TO THE USER NOT MAINTAINING THE DEVICE PER PROPER HANDLING. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME WAS CHEWING UP THE SKIN TISSUE. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE DONOR TISSUE "LOOKED LIKE SWISS CHEESE," AND WAS UNABLE TO BE USED. AN ADDITIONAL GRAFT HARVEST WAS REQUIRED. THE SURGICAL TIME WAS EXTENDED BY LESS THAN TEN MINUTES WHICH WAS REQUIRED TO OBTAIN AND SET-UP AND ALTERNATE, IMMEDIATELY AVAILABLE DEVICE FOR THE ADDITIONAL DONOR SITE HARVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181785 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1