BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME KIT

    MDR report key: 3853148 · Received April 2, 2014

    Report

    Report Number
    1526350-2014-00242
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 3, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ON MAY 31, 2012, US AND CANADIAN CUSTOMERS WERE SENT AN URGENT PT 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 MFR FOR REPAIR AND EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 08/24/2004 AND WAS LAST REPAIRED ON 05/25/2012 FOR A NON-RELATED ISSUE. EVAL OF THE DEVICE OBSERVED WEAR TO THE HOSE POWER SOURCE CONNECTOR AND DAMAGE TO THE HEAD. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE OF CALIBRATION SPECS AT ZERO THICKNESS SETTINGS AND OUTSIDE SIDE TO SIDE CALIBRATION AT THE ZERO THICKNESS SETTING. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE HEAD, AIR HOSE, CONTROL BAR, SCREW DRIVER AND STANDARD REPAIR PARTS. IN POST REPAIR ANALYSIS, CORROSION TO THE RECIPROCATING ARM WAS OBSERVED AND THE SHAFT OF THE MOTOR WAS MANUALLY ROTATED WITH UNUSUAL RESISTANCE. THE CUSTOMER'S REPORTED EVENT WAS NOT REPRODUCED DURING TESTING; HOWEVER, THE UNIT'S LACK OF CALIBRATION MOST LIKELY CAUSED THE AIR DERMATOME TO TAKE AN UNEVEN GRAFT. THIS LACK OF CALIBRATION IS MOST LIKELY DUE TO LACK OF PREVENTATIVE MAINTENANCE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME CUT UNEVENLY. THERE WAS NO PT HARM OR DELAY REPORTED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200527 AIR DERMATOME KIT AIR DERMATOME KIT GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1