BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3834732 · Received March 20, 2014

    Report

    Report Number
    1526350-2014-00210
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    August 12, 2013
    Report Date
    March 18, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THAT THE DEVICE WAS MANUFACTURED ON 08/24/1995 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. EVALUATION OF THE DEVICE OBSERVED THE COMB WAS BENT, THE LATCHING PINS WERE STUCK IN THE LOCKED POSITION, AND THE SIDE PLATES WERE DENTED. THE CUSTOMER DID NOT RETURN A RATCHET OR ANY CUTTERS FOR EVALUATION. PRIOR TO REPAIR, BOTH THE TEST MESH AND THE CALIBRATION CHECK COULD NOT BE PERFORMED DUE TO THE DAMAGED COMB AND THE INABILITY TO UNLOCK THE LATCHING PIN. REPAIR OF THE CARRIER GUIDE AND BOTH SIDE PLATES. THE BALL DETENTS ARE THE COMPONENT THAT ALLOW THE LATCHING PINS TO LOCK/UNLOCK. THE DEVICE HAS NOT BEEN RETURNED TO ZIMMER SURGICAL FOR MAINTENANCE OR REPAIRS SINCE MANUFACTURE 18 YEARS AGO; THEREFORE, LACK OF PREVENTATIVE MAINTENANCE MOST LIKELY CAUSED THE DAMAGE TO THE COMB AND THE DYSFUNCTIONALITY OF THE LATCHING PINS, 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 WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER UNIT DID NOT WORK. 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
    165300 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1