BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3823783 · Received February 20, 2014

    Report

    Report Number
    1526350-2014-00102
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 22, 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 EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 08/23/2010 AND WAS LAST REPAIRED ON 04/10/2013 FOR RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED WORN GEARS, AS EXCESSIVE GALLING OF THE GEAR TEETH OF THE ROLLER GEAR AND BOTH CUTTER GEARS WAS OBSERVED. THE, THE COMB WAS OBSERVED TO BE DAMAGED. PRIOR TO REPAIR, TEST MESH AND ADDITIONALLY CHECK COULD NOT BE PERFORMED DUE TO THE DAMAGED GEARS. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE ROLLER AND ROLLER GEAR, COMB, BOTH SIDE PLATES, AND CARRIER GUIDE. THE CUSTOMER RETURNED TWO CUTTERS FOR EVALUATION. THE GEARS AND BUSHINGS WERE REPLACED TO BOTH CUTTERS, WHICH PASSED EVALUATION. 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 GEAR, BOTH CUTTER GEARS AND COMB, WHICH MOST LIKELY CAUSED THE CUSTOMERS REPORTED EVENT. THE DEVICE WAS SERVICES 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 WAS HARD TO CRANK. IT WAS NOTED THAT THE 1.5:1 CUTTER, SERIAL NUMBER (B)(4) WAS NOT MESHING. THE FACILITY REPORTING THE EVENT IS A CADAVER TISSUE BANK. AS SUCH, THERE WAS NO REPORT OR PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106579 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ZIMMER CUTTER: 00-7703-015-00, SN (B)(4)| ZIMMER CUTTER: 00-7703-020-00, SN (B)(4)