BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME KIT

    MDR report key: 2092599 · Received May 9, 2011

    Report

    Report Number
    1526350-2011-00092
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. THE SERVICE REPORTS INDICATE THAT THE DEVICE HAS NOT BEEN IN FOR SERVICE SINCE PURCHASED IN 2008. THE INSPECTION FOUND THAT THE DEVICE WAS OUT OF CALIBRATION AT THE 0 AND THICKNESS LEVER SETTING, HOWEVER, THIS WOULD NOT IMPACT GRAFTING ABILITY. THERE WERE SMALL DENTS AND SCRATCHES ON THE HEAD AND CONTROL BAR. UNABLE TO DETERMINE THE CAUSE OF THE REPORTED COMPLAINT. THE DEVICE IS OUT OF CALIBRATION AND THE DAMAGE TO THE HEAD AND CONTROL BAR ARE INDICATIVE OF A LACK OF PREVENTATIVE MAINTENANCE. RECORDS INDICATE THIS DEVICE HAS NOT BEEN RETURNED TO ZIMMER FOR SERVICE SINCE ITS PURCHASE IN (B)(6) 2008. THE ZIMMER AIR DERMATOME SHOULD BE RETURNED EVERY 12 MONTHS AND THE HOSE EVERY 6 MONTHS FOR INSPECTION AND PREVENTATIVE 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 BLADE WOBBLES, TORE THE PATIENT'S SKIN AND STITCHES WERE NEEDED, AS STATED BY THE SURGEON.

    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