BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER AIR DERMATOME HANDPIECE

    MDR report key: 4092301 · Received August 20, 2014

    Report

    Report Number
    1526350-2014-00414
    Event Type
    Injury
    Date Received
    August 20, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 21, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 DEVICE INFORMING THEM OF IMPROPERLY MAINTAINING INSTRUMENTS THAT MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON (B)(6) 2011 AND WAS PREVIOUSLY RETURNED FOR REPAIR ON (B)(6) 2013 FOR A NON-RELATED ISSUE. INVESTIGATION REVEALED THAT THE DEVICE PERFORMED WITHIN MOTOR SPEED SPECIFICATIONS. THE REPORTED EVENT WAS NOT REPRODUCED. PRIOR TO REPAIR, THE DEVICE MET CALIBRATION SPECIFICATIONS AT ALL TESTED THICKNESS SETTINGS EXCEPT FOR THE ZERO THICKNESS SETTING. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF ALL STANDARD REPAIR PARTS. THE CUSTOMER'S REPORTED EVENT WAS NOT REPRODUCED DURING TESTING; THEREFORE, A CAUSE CANNOT 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 HANDPIECE WAS NOT RUNNING AT ALL. CLINICAL FOLLOW-UP REVEALED THAT THE DEVICE MALFUNCTIONED DURING A SURGERY WHERE THE DERMATOME TOOK A DEEPER CUT THAN EXPECTED. THE SURGEON STOPPED WITH THAT GRAFT AND PROCEEDED TO TAKE A FULL THICKNESS GRAFT BY HAND. THE REPORTED NURSE MADE THE COMMENT THAT SHE DIDN'T KNOW IF IT WAS THE DOCTOR OR THE DERMATOME THAT CAUSED THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503720 ZIMMER AIR DERMATOME HANDPIECE ZIMMER AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1