BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 1587679 · Received January 20, 2010

    Report

    Report Number
    1526350-2010-00004
    Event Type
    Malfunction
    Date Received
    January 20, 2010
    Date of Event
    November 1, 2009
    Report Date
    January 12, 2010
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE WAS FOUND TO HAVE AN IMPROPER CONTROL BAR POSITION AND A MOTOR THAT WAS WITHIN RPM SPECIFICATIONS, BUT RAN ROUGH. UNIT ALSO HAD WORN VESPEL AND SEMI-CIRCLE SHAFT BEARINGS. THIS DEVICE WAS LAST IN FOR CALIBRATION AND PREVENTIVE MAINTENANCE, AT ZIMMER OSP, IN 08/2005. THE ALLEGED MALFUNCTION OF THE DEVICE NOT ENGAGING PROPERLY OVER THE SKIN IS LIKELY DUE TO THE CONTROL BAR BEING OUT OF POSITION, WHICH MAY IN TURN HAVE RESULTED FROM THE WORN VESPEL AND SEMI-CIRCLE SHAFT BEARINGS. INSTRUCTION MANUAL INCLUDED WITH THE DEVICE STATES THAT "THE ZIMMER ELECTRIC DERMATOME SHOULD BE RETURNED EVERY 12 MONTHS FOR INSPECTION AND PREVENTATIVE MAINTENANCE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME WAS NOT ENGAGING PROPERLY OVER THE SKIN. ADDITIONAL INFORMATION RECEIVED ON 01/12/2010, THE SKIN GRAFT EDGES WERE TORN AND RAGGED. SURGEON WAS ONLY ABLE TO HARVEST A PARTIAL GRAFT. THERE WAS NO REPORT OF INJURY OR ADVERSE PATIENT CONSEQUENCES ASSOCIATED WITH THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR