BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3912550 · Received May 14, 2014

    Report

    Report Number
    1526350-2014-00354
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 JULY 19, 1995 AND WAS LAST REPAIRED ON JANUARY 10, 2002 FOR A NON-RELATED ISSUE. INVESTIGATION REVEALED DAMAGE TO THE HEAD, HOUSING SHAFT AND CONTROL BAR. THE MASTER BLADE WAS NOT FLUSH WITH THE LEADING EDGE OF THE CONTROL BAR. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS AT THE ZERO, 00100" AND 0.0200" THICKNESS SETTINGS. THE DEVICE WAS ALSO OUTSIDE SIDE TO SIDE CALIBRATION SPECIFICATIONS AT ALL TESTED THICKNESS SETTINGS. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE HEAD, HOUSING SHAFT, CONTROL BAR AND STANDARD REPAIR PARTS. POST REPAIR ANALYSIS REVEALED CORROSION TO THE HEAD, HOUSING SHAFT, BEARING STACK AND RECIPROCATING ARM. THE DEVICE HAS NOT BEEN RETURNED TO ZIMMER SURGICAL FOR MAINTENANCE OR REPAIR IN TWELVE YEARS; THEREFORE, LACK OF PREVENTATIVE MAINTENANCE MOST LIKELY CAUSED THE LACK OF CALIBRATION OF THE UNIT, WHICH MOST LIKELY CAUSED THE CUSTOMER'S REPORTED EVENT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING SURGERY, THE ZIMMER AIR DERMATOME HANDPIECE PRODUCED A GRAFT WHERE THERE WAS IRREGULAR THICKNESS. THE GRAFT WAS ABLE TO BE USED AND THERE WAS NO PATIENT HARM OR DELAY REPORTED. NO ALTERNATE DEVICE WAS RETRIEVED FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288357 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1