BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3237912 · Received July 17, 2013

    Report

    Report Number
    1526350-2013-00382
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING MAY 21, 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 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 10/23/1996 AND WAS LAST REPAIRED ON 08/21/2010 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE DETERMINED THAT THE CONTROL BAR WAS LOOSE AND THE MASTER BLADE WAS NOT FLUSH. PRIOR TO REPAIR, THE DEVICE WAS WITHIN THICKNESS CALIBRATION SPECIFICATIONS AT ALL SETTINGS. TESTING OF THE DEVICE CONFIRMED THE MOTOR TO OPERATE AT A CONSTANT SPEED WITHIN SPECIFICATIONS. THE LOOSE CONTROL BAR COULD HAVE AFFECTED THE CUTTING ABILITY OF THE DERMATOME; HOWEVER IT SHOULD NOT HAVE CAUSED THE REPORTED EVENT THAT THE AIR DERMATOME WAS "BROKEN AND DID NOT WORK." THE REPORTED EVENT COULD NOT BE REPRODUCED AND THE CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME WAS BROKEN AND DID NOT WORK. AN ADDITIONAL DERMATOME WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332624 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1