BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME II HANDPIECE

    MDR report key: 3810999 · Received March 24, 2014

    Report

    Report Number
    1526350-2014-00218
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    December 1, 2013
    Report Date
    March 20, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ON MAY 31, 2012, US AND (B)(6) CUSTOMERS WERE SENT AN URGENT PATIENT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTATIVE 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 MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THT THE DEVICE WAS MANUFACTURED ON 08/23/2012 AND HAS NO PREVIOUS REPAIR HISTORY AT ZIMMER SURGICAL. EVALUATION OF THE DEVICE OBSERVED THE MASTER WIDTH PLATE DID NOT FIT PROPERLY IN THE DEVICE AND THE MASTER BLADE WAS NOT POSITIONED PROPERLY WITH THE CONTROL BAR. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS AT ALL TESTED THICKNESS SETTINGS. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE GEARS, GEAR RING, HEAD, NECK, RETURNED WIDTH PLATES, AND ALL STANDARD REPAIR PARTS. CUSTOMER DID NOT RETURN ANY ASSOCIATED BLADES FOR EVALUATION AND NO INFORMATION IS KNOWN REGARDING THE POWER SOURCE OR PRESSURE SETTING UTILIZED DURING THE REPORTED EVENT. THE CUSTOMER'S REPORTED EVENT WAS LIKELY CAUSED BY THE DEVICE BEING OUTSIDE OF CALIBRATION SPECIFICATION, IMPROPER FITMENT OF THE WIDTH PLATES AND IMPROPER POSITIONING OF THE CONTROL BAR, WHICH WAS LIKELY CAUSED BY THE CUSTOMER NOT MAINTAINING THE DEVICE PER PROPER HANDLING. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME II HANDPIECE WAS NOT WORKING CORRECTLY. THERE WAS NO PATIENT HARM OR DELAY REPORTED. DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE CUSTOMER, NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173557 ZIMMER AIR DERMATOME II HANDPIECE ZIMMER AIR DERMATOME II HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1