BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 2852449 · Received November 13, 2012

    Report

    Report Number
    1526350-2012-00290
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 31, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 MFG ON 04/28/2012. UPON INVESTIGATION OF THE DEVICE, THE RATCHET MECHANISM WAS FOUND TO HAVE A STUCK GEAR AND WOULD NOT OPERATE. THE CUSTOMER'S CUTTER WAS NICKED AND DID NOT PRODUCE AN ACCEPTABLE TEST MESH. A RATCHET THAT WOULD NOT OPERATE COULD HAVE CAUSED THE CUSTOMER'S EVENT. PER THE INSTRUCTIONS FOR USE, THE RATCHET IS A USER SERVICEABLE DEVICE THAT CAN BE DISASSEMBLED TO FACILITATE EASY CLEANING AND MAINTENANCE. THE CAUSE IS LIKELY THE USER NOT MAINTAINING THE DEVICE PER PROPER HANDLING. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER DEVICE WAS NOT ABLE TO BE USED TO MESH THE TISSUE. SEVERAL ATTEMPTS WERE TRIED USING DIFFERENT CARRIERS BUT THE RATCHET HANDLE WOULD NOT ADVANCE THE CARRIER(S). AN ALTERNATE NON-ZIMMER DEVICE WAS USED TO COMPLETE THE PLANNED PROCEDURE. THE CUSTOMER REPORTED THE SURGICAL TIME WAS INCREASED BY APPROXIMATELY ONE HOUR DUE TO TIME SPENT MAKING MULTIPLE ATTEMPTS AND OBTAINING AN ALTERNATE DEVICE TO COMPLETE THE PLANNED PROCEDURE. THE CUSTOMER STATED THERE WAS NO ADDITIONAL HARVEST, MEDICAL/SURGICAL INTERVENTION, OR DOCUMENTED COMPLICATIONS OF EXTENDED SURGICAL TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1