BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3851062 · Received February 12, 2014

    Report

    Report Number
    1526350-2014-00084
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 15, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(6) 2012, US AND (B)(6) CUSTOMERS WERE SENT AN URGENT PATIENT 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 FOE THE DEVICE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 07/24/1990 AND WAS LAST REPAIRED ON 06/21/2012 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED MINOR WEAR TO THE HAND PIECE. THE LEADING EDGE OF THE CONTROL BAR WAS FLUSH WITH THE MASTER BLADE AND THE MOTOR SPEED WAS WITHIN SPECIFICATIONS. THERE WERE NO VISIBLE ISSUES WITH THE RETURNED 2" WIDTH PLATE. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS ONLY AT THE ZERO THICKNESS SETTING ON THE LEFT SIDE AND THE SIDE TO SIDE. CUSTOMER DID NOT RETURN ANY ASSOCIATED BLADES WITH THE DEVICE. THE CUSTOMER'S REPORTED EVENT WAS NOT REPRODUCED DURING TESTING AND A CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED; HOWEVER, THE LACK OF CALIBRATION IS LIKELY DUE TO THE USER NOT MAINTAINING THE DEVICE PER PREVENTATIVE MAINTENANCE AND IMPROPER HANDLING. NO INFORMATION IS KNOWN REGARDING THE TECHNIQUE OR METHODS UTILIZED DURING THE REPORTED EVENT; HOWEVER, INCORRECT USER TECHNIQUE COULD HAVE CAUSED THE DEVICE TO IMPROPERLY CUT THE MIDDLE OF THE SKIN GRAFT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME WAS NOT CUTTING PROPERLY IN THE MIDDLE OF THE SKIN GRAFT. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93781 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1