BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME HANDPIECE

    MDR report key: 2980657 · Received February 22, 2013

    Report

    Report Number
    1526350-2013-00091
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE IS 16 YRS OLD AND WAS LAST RETURNED TO THE MFR FOR REPAIR ON (B)(4) 2012. PRIOR TO REPAIR, THE DEVICE DISPLAYED DAMAGE TO THE HEAD OF THE DEVICE AND OVER TIGHTENING OF THE 2 AND 3 INCH WIDTH PLATES. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE OF CALIBRATION SPECIFICATIONS AT THE ZERO THICKNESS SETTING ON THE LEFT SIDE. DAMAGE TO THE HEAD OF THE DEVICE AND LACK OF CALIBRATION MOST LIKELY CAUSED THE CUSTOMER'S EVENT. CLINICAL F/U DID NOT REVEAL WHAT WIDTH PLATE THE CUSTOMER UTILIZED DURING THE SURGERY. THE CAUSE IS LIKELY THE USER NOT MAINTAINING THE DEVICE PER IMPROPER HANDLING. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER DERMATOME WAS NOT CUTTING PROPERLY. ADDITIONAL CLINICAL F/U WITH THE HOSP INDICATED THAT THE DEVICE WAS OBSERVED TO HAVE "A GAP OF APPROXIMATELY 1/4 INCH ON ONE SIDE." NO FURTHER INFO WAS AVAILABLE REGARDING WHETHER THIS DEVICE WAS USED FOR PT TREATMENT. HOWEVER, NO PT INJURY OR ADVERSE OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77632 ZIMMER AIR DERMATOME HANDPIECE ZIMMER AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1