BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3241105 · Received July 18, 2013

    Report

    Report Number
    1526350-2013-00391
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(6) 2002, US AND (B)(6) CUSTOMERS WERE SENT AN URGENT PT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR ZIMMER AIR DERMATOME. CUSTOMERS WERE INFORMED THAT IMPROPERLY MAINTAINED INSTRUMENTS MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. CUSTOMERS WERE REQUESTED TO CONTACT ZIMMER TO SCHEDULE MAINTENANCE FOR THE DEVICE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVALUATION. THE SVC RECORD INDICATES THAT THE DEVICE WAS MFG ON 02/16/1996 AND WAS LAST REPAIRED ON 04/06/2001 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED THAT THE THICKNESS CONTROL LEVER WAS VERY DIFFICULT TO TURN. A TORQUE TEST WAS PERFORMED AND REVEALED THAT THE TORQUE WAS OUTSIDE OF SPECIFICATION. IT WAS ALSO OBSERVED THAT THE HOSE, HEAD, WIDTH PLATES AND CONTROL BAR WERE DAMAGED. 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 THE THICKNESS CONTROL LEVER ON THE ZIMMER AIR DERMATOME NOT WORKING. ADD'L CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE ISSUE WAS FOUND DURING STERILE PROCESSING AND THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336442 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1