BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3912549 · Received May 14, 2014

    Report

    Report Number
    1526350-2014-00356
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    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 9/8/2010 AND WAS LAST REPAIRED ON 1/7/2014 FOR A RELATED EVENT. EVALUATION OF THE DEVICE OBSERVED THAT THE COMB, ROLLER AND ROLLER GEAR WERE DAMAGED. IT WAS ALSO NOTED THAT BOTH CUTTER'S GEAR TEETH WERE DAMAGED. PRIOR TO REPAIR, BOTH THE TEST MESH AND THE CALIBRATION CHECK COULD NOT BE PERFORMED DUE TO THE DAMAGED COMB. BOTH CUTTERS DID NOT PASS CUTTER EVALUATION AND WERE RETURNED TO THE CUSTOMER AS NON-REPAIRABLE. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE COMB, ROLLER AND ROLLER GEAR, CUTTER GEARS, COLLARS AND BUSHINGS. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. THE CUTTERS WERE RETURNED TO THE CUSTOMER AS NON-REPAIRABLE. THE CAUSE OF THE REPORTED ISSUE REVEALED THAT IMPROPER HANDLING BY THE USER MOST LIKELY CAUSED THE DAMAGE TO THE COMB, CUTTER AND ROLLER GEARS AND CUTTERS, WHICH MOST LIKELY CONTRIBUTED TO THE CUSTOMER'S REPORTED EVENT REGARDING THE DAMAGED GEARS AND THE DEVICE PRODUCING AN INCOMPLETE MESH. IT SHOULD BE NOTED THAT BOTH CUTTERS WERE PREVIOUSLY RETURNED TO THE CUSTOMER AS NON-REPAIRABLE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALL GEARS OF THE ZIMMER SKIN GRAFT MESHER WERE DAMAGED PRODUCING AN INCOMPLETE MESH. 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
    288206 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ZIMMER SKIN GRAFT MESHER CUTTER 2:1 RATIO 911046| ZIMMER SKIN GRAFT MESHER CUTTER 1.5:1,| RATIO 1203008