BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME II HANDPIECE

    MDR report key: 4172221 · Received October 9, 2014

    Report

    Report Number
    1526350-2014-00443
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    August 1, 2014
    Report Date
    October 8, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 11/29/2012 AND WAS LAST REPAIRED ON (B)(4) 2013 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED THAT THE MISPOSITIONED CONTROL BAR AND NICKS TO THE HEAD COULD HAVE CONTRIBUTED TO SUB-OPTIMAL BEHAVIOR OF THE DEVICE; HOWEVER, IT OPERATED AS INTENDED DURING TESTING. FURTHER EVALUATION REVEALED BUBBLING / BLISTERING OF THE 3" WIDTH PLATE, RENDERING THE DEVICE NON-REPAIRABLE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED AS THE DEVICE FUNCTIONED PROPERLY DURING TESTING. THE DEVICE HAS NOT BEEN RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE ZIMMER AIR DERMATOME II HANDPIECE IS NOT WORKING PROPERLY AND NEEDS ITS ANNUAL CHECKUP. ADDITIONALLY THE DEVICE WILL BE REVIEWED FOR BUBBLING/BLISTERING OF THE SURFACE COAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636899 ZIMMER AIR DERMATOME II HANDPIECE ZIMMER AIR DERMATOME II HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1