BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER AIR DERMATOME II HANDPIECE

    MDR report key: 2970946 · Received February 15, 2013

    Report

    Report Number
    1526350-2013-00068
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 10/17/2012 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. PRIOR T REPAIR THE UNIT WAS WITHIN CALIBRATION SPECIFICATIONS. DURING REPAIR IT WAS NOTED THAT THE SCREWS HOLDING THE HEAD ON THE NECK OF THE UNIT WERE STRIPPED. THE GALL MARKS ON THE HEAD MOST LIKELY CAUSED THE CUSTOMER'S EVENT. THE GALLING OF THE HEAD WAS MOST LIKELY CREATED BY OVER-TIGHTENING OF THE WIDTH PLATE CAUSING THE DERMATOME BLADE TO RUB AGAINST THE LEADING EDGE OF THE HEAD. CUSTOMER DID NOT RETURN THE DERMATOME BLADE FOR ANALYSIS AGAINST THE DERMATOME. THE CAUSE IS MOST LIKELY IMPROPER PREPARATION FOR USE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE ZIMMER DERMATOME FOR A SKIN GRAFT, IT STARTING MAKING UNUSUAL NOISES AND SKIPPED, TEARING THE GRAFT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE FOR AN ADDITIONAL DONOR HARVEST TO COMPLETE THE INTENDED WOUND COVERAGE. THERE WAS A REPORTED TEN MINUTES OF ADDITIONAL SURGICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69563 ZIMMER AIR DERMATOME II HANDPIECE ZIMMER AIR DERMATOME II HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1