BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 2794085 · Received October 11, 2012

    Report

    Report Number
    1526350-2012-00251
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 12, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE IS 19 YEARS OLD AND WAS LAST RETURNED TO THE MANUFACTURER FOR REPAIR ON 08/18/1994. INVESTIGATION OF DEVICE REVEALED A DAMAGED HEAD AND CONTROL BAR. THE DEVICE WAS ALSO OUT OF CALIBRATION ON THE LEFT SIDE AT EVERY SETTING. THE WIDTH PLATES WERE NICKED AND SCRATCHED ON THE LEADING EDGE. ANY OF THESE FINDINGS COULD HAVE LED TO THE CUSTOMER'S EVENT. THE CAUSE IS MOST LIKELY DUE TO THE USER NOT MAINTAINING THE DEVICE PER PREVENTIVE MAINTENANCE AND HANDLING ACCORDING TO THE INSTRUCTIONS FOR USE. 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 WHILE USING THE ZIMMER DERMATOME, TISSUE GOT STUCK IN THE DEVICE. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE HARVESTED TISSUE WAS FULL THICKNESS AND BECAME STUCK UNDER THE DERMATOME AND WAS ROLLED INTO A BALL. THE HARVESTED GRAFT WAS EXCISED FROM THE PATIENT BY SCISSORS AND THE EDGES OF THE DONOR SITE REQUIRED A SURGICAL REPAIR. THE INITIAL GRAFT WAS NOT USABLE FOR THE PLANNED PROCEDURE AND AN ADDITIONAL DONOR SITE HARVEST WAS REQUIRED. THE CUSTOMER STATED AN ADDITIONAL UNIT WAS IMMEDIATELY AVAILABLE FOR THE COMPLETION OF THE PROCEDURE. THE SURGICAL TIME WAS STATED TO HAVE BEEN INCREASED BY THIRTY MINUTES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1