BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3010850 · Received March 14, 2013

    Report

    Report Number
    1526350-2013-00130
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    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 EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE IS 3 YEARS OLD AND WAS LAST RETURNED TO THE MFR FOR REPAIR ON (B)(4) 2012. PREVIOUS REPAIR DID OBSERVE REPLACEMENT OF THE ROLLER GEAR, SIDE PLATES, COMB AND BUSHINGS. THE REPORTER IS A CADAVER TISSUE BANK WHICH EXPERIENCES FREQUENT USAGE OF DEVICES. INSPECTION OF THE DEVICE DISPLAYED AN EXCESSIVELY WORN GEAR ON THE ROLLER AND WORN GEARS ON THE CUTTER GEARS. CALIBRATION PRIOR TO REPAIR COULD NOT BE DETERMINED DUE TO DAMAGE TO THE ROLLER GEAR. THE DEVICE WAS REPAIRED WITH A ROLLER GEAR. THE GEARS WERE REPLACED ON THE TWO CUTTERS THAT WERE RETURNED ALONG WITH THE DEVICE. HOWEVER, AFTER REPAIRING THE GEARS ON THE CUTTERS, ONLY THE 2:1 CUTTER MET ACCEPTABLE CRITERIA. THE 1.5:1 CUTTER WAS DETERMINED TO BE DAMAGED AND NON-REPAIRABLE. IMPROPER HANDLING AND FREQUENT USAGE MOST LIKELY CAUSED THE DAMAGE TO THE ROLLER AND CUTTER GEARS, WHICH MOST LIKELY CAUSED THE DAMAGE TO THE ROLLER AND CUTTER GEARS, WHICH MOST LIKELY CAUSED THE 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 CUTTER, SERIAL #(B)(4), WAS NOT MESHING PROPERLY. THE FACILITY REPORTING INFO IS A CADAVER TISSUE BANK. THERE WAS NO REPORT OF INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108299 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00-7703-015-00, SN #1109019| 00-7703-020-00, SN #1109052