BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3894281 · Received February 14, 2014

    Report

    Report Number
    1526350-2014-00094
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 17, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 WAS MANUFACTURED ON 09/08/2010 AND WAS LAST REPAIRED ON 06/19/2013 FOR A NON-RELATED ISSUE. EVAL OF THE DEVICE OBSERVED WORN GEARS, EXCESSIVE GALLING OF THE ROLLER GEAR AND CUTTER GEAR TEETH. MINOR WEAR TO THE SHOULDER BOLTS AND DAMAGE TO THE SIDE PLATES AND ROLLER WERE ALSO OBSERVED. PRIOR TO REPAIR, A TEST MESH AND CALIBRATION CHECK COULD NOT BE PERFORMED DUE TO THE DAMAGED GEARS, THE CUSTOMER RETURNED CUTTERS FOR EVAL. EXCESSIVE GALLING OF THE CUTTER GEAR TEETH WAS OBSERVED FOR BOTH CUTTERS. THE GEARS AND COLLARS WERE REPLACED TO BOTH CUTTERS, WHICH PASSED CUTTER EVAL. IT WAS NOTED THAT THE CUSTOMER IS A CADAVER TISSUE BANK WHICH EXPERIENCES HEAVY USAGE OF DEVICES. IMPROPER HANDLING BY THE USER MOST LIKELY CAUSED DAMAGE TO THE ROLLER AND BOTH CUTTER GEARS, WHICH MOST LIKELY CAUSED THE CUSTOMER REPORTED EVENT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEARS WERE DAMAGED ON THE ZIMMER SKIN GRAFT MESHER AND THE DEVICE WOULD NOT MESH PROPERLY. IT WAS ALSO REPORTED THAT IT WAS HARD TO CRANK. THE FACILITY REPORTING THE EVENT IS A CADAVER TISSUE BANK. AS SUCH, THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98106 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00-7703-015-00, SN#(B)(4),| ZIMMER SKIN GRAFT MESHER CUTTERS:| 00-7703-020-00, SN#(B)(4).