BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME KIT

    MDR report key: 2003718 · Received February 23, 2011

    Report

    Report Number
    1526350-2011-00028
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 24, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. THE SERVICE RECORDS INDICATE THAT THE DEVICE HAS NOT BEEN IN FOR SERVICE SINCE PURCHASED IN 2008. THE INSPECTION FOUND THAT THE DEVICE HAD A WEAK MOTOR. THE WEAK MOTOR MAY HAVE CONTRIBUTED TO AN INCONSISTENT CUT. IN ADDITION, THE CONTROL BAR SETTING WAS FOUND TO BE OUT OF CALIBRATION. THE CAUSE OF THE REPORTED ISSUE IS POSSIBLY DUE TO THE WEAK MOTOR, THE DEVICE WAS OUT OF CALIBRATION AND A LACK OF PREVENTIVE MAINTENANCE. THE ZIMMER AIR DERMATOME INSTRUCTION MANUAL PROVIDES INSTRUCTIONS FOR DEVICE INSPECTION PRIOR TO OPERATING, AND FOR CUTTING THE GRAFT. THE ZIMMER AIR DERMATOME SHOULD BE RETURNED EVERY 12 MONTHS AND THE HOSE EVERY 6 MONTHS FOR INSPECTION AND PREVENTIVE MAINTENANCE. ANNUAL FACTORY CALIBRATION CHECKS ARE STRONGLY RECOMMENDED TO VERIFY CONTINUED ACCURACY. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME DEVICE WAS CUTTING SHORT GRAFT AND BOUNDS WHEN IT TOOK THE SKIN. ADDITIONAL CLINICAL FOLLOW UP RECEIVED FROM THE HOSPITAL ON "(B)(6) 2011" INDICATED THAT AN ADDITIONAL GRAFT WAS HARVESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1