BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3172279 · Received June 5, 2013

    Report

    Report Number
    1526350-2013-00295
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVAL. THE DEVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 6/21/1991 AND WAS LAST REPAIRED ON 2/8/2013 FOR A NON-RELATED ISSUE. EVAL OF THE DEVICE OBSERVED THAT THE POPPET WAS STUCK DOWN IN THE ON POSITION. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE OF CALIBRATION SPECIFICATIONS AT THE ZERO THICKNESS SETTING ON THE RIGHT SIDE AND THE SIDE TO SIDE CALIBRATION. DURING POST REPAIR ANALYSIS THE POPPET ASSEMBLY WAS ANALYZED AND FUNCTIONED NORMALLY. THE POPPET ASSEMBLY WAS DISASSEMBLED AND ANALYZED. DURING INSPECTION. SOME SILICONE WAS OBSERVED IN AND AROUND THE SPRING. INSPECTION OF THE HOUSING REVEALED THAT IT WAS MANUFACTURED PER SPECIFICATIONS. THE CAUSE IS MOST LIKELY DEBRIS IN THE SPRING OF THE POPPET ASSEMBLY; HOWEVER, THE DEVICE BEING OUT OF CALIBRATION ALSO DEMONSTRATES THE USER NOT MAINTAINING THE DEVICE PER HANDLING. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME WAS NOT WORKING RIGHT. DURING DEVICE ANALYSIS. IT WAS DETERMINED THAT THE POPPET ASSEMBLY WAS OBSERVED TO BE STUCK IN THE ON POSITION. THE POPPET BEING STUCK IN THE ON POSITION COULD RESULT IN THE DEVICE RUNNING UNEXPECTEDLY, WITHOUT USER ACTIVATION, AND COULD RESULT IN INJURY TO THE PT OR THE USER OF THE MALFUNCTION WERE TO RECUR. CLINICAL FOLLOW UP WITH THE CUSTOMER COULD NOT PROVIDE ANY ADDITIONAL INFO REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249145 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1