BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3573403 · Received November 1, 2013

    Report

    Report Number
    1526350-2013-00631
    Event Type
    Malfunction
    Date Received
    November 1, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 2, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING MAY 31, 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 SKIN GRAFT MESHER. 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 MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 12/19/1989 AND WAS LAST REPAIRED ON 07/23/2010 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED DAMAGE TO THE HEAD AND CONTROL BAR AND THE DEVICE DID NOT OPERATE. THERE WAS ALSO WEAR TO THE HOSE AND THE HOSE LEAKED AT THE POWER SOURCE CONNECTOR WHEN CONNECTED TO A POWER SOURCE. ALL WIDTH PLATES WERE NICKED; HOWEVER, THE NICKS TO THE 2" AND 3" WIDTH PLATES WERE MINOR. ADDITIONALLY, DAMAGE WAS OBSERVED TO THE HEAD, CONTROL BAR, WIDTH PLATES AND THREADS OF THE POPPET HOUSING. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE OF CALIBRATION SPECIFICATIONS AT THE ZERO THICKNESS SETTINGS ON THE LEFT AND RIGHT SIDE. THE DEVICE WAS ALSO OUT OF CALIBRATION ON THE SIDE TO SIDE FOR ALL THICKNESS SETTINGS. THE CAUSE IS LIKELY THE USER NOT MAINTAINING THE DEVICE PER PREVENTATIVE MAINTENANCE AND IMPROPER HANDLING. 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 NOT SHAVING THE SKIN EVENLY. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL CLINICAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564770 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1