BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3823810 · Received February 20, 2014

    Report

    Report Number
    1526350-2014-00098
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    September 1, 2013
    Report Date
    January 21, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(6) 2012, USA AND (B)(6) CUSTOMERS WERE SENT TO URGENT PT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR ZIMMER SKIN GRAFT MESHER. CUSTOMERS WERE INFORMED THAT IMPROPERLY MAINTAINED INSTRUMENTS MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. CUSTOMERS WERE REQUESTED TO CONTACT ZIMMER TO SCHEDULE MAINTENANCE FOR THE DEVICE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 12/06/2006 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. EVALUATION OF THE DEVICE OBSERVED THAT THE SLIDING PIN AND SPRING IN THE RATCHET DID NOT ENGAGE. A TINE ON THE LEFT SIDE OF THE COMB WAS BENT. MINOR GNARLING AND GALLING OF THE RIGHT END OF THE ROLLER WAS OBSERVED AND THE LOWER GEAR GUARD DISPLAYED MINOR DEFORMATION IT WAS ALSO OBSERVED THAT THE SLIDING PIN WAS TURNED SIDEWAYS AND WAS NOT CATCHING THE RATCHET GEAR. PRIOR TO REPAIR, A TEST MESH PASSED, BUT THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS ON THE LEFT AND RIGHT SIDE. CUSTOMER MOST LIKELY ALERTED THE POSITION OF THE SLIDING PIN IN THE RATCHET, CAUSING THE RATCHET TO BECOME NON-FUNCTIONAL. ADDITIONALLY, LACK OF PREVENTATIVE MAINTENANCE BY THE CUSTOMER MOST LIKELY ALLOWED FOR THE DAMAGE TO COMB, ROLLER AND LOWER GEAR GUARD OVER TIME, AS THE DEVICE HAS NOT BEEN RETURNED TO ZIMMER SURGICAL FOR THE REPAIR SINCE MFR EIGHT YEARS AGO. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE RATCHET WAS BROKEN. DURING DEVICE EVALUATION, IT WAS OBSERVED THAT THE COMB WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106856 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1