BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3113989 · Received May 8, 2013

    Report

    Report Number
    1526350-2013-00233
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 01/09/1992 AND WAS LAST REPAIRED ON (B)(6) 2012. EVAL OF THE DEVICE VERIFIED THAT THE COMB, ROLLER AND LEFT SIDE PLATE WERE DAMAGED. A TEST MESH AND CALIBRATION COULD NOT BE PERFORMED DUE TO DAMAGE OF THE COMB. THREE CUTTERS WERE RETURNED WITH DEVICE. CUTTER EVAL DETERMINED THAT BOTH 3.0:1 AND 4.0:1 CUTTERS PRODUCED ACCEPTABLE TEST MESHES. HOWEVER, THE 2.0:1 CUTTER PRODUCED AN UNACCEPTABLE TEST MESH. 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 HAD A BENT COMB. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE REPORTED ISSUE WAS OBSERVED IN THE STERILE PROCESSING DEPARTMENT AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202418 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00-7703-040-00, SERIAL NUMBER: (B)(4)| 00-7703-020-00, SERIAL NUMBER: (B)(4)| 00-7703-030-00, SERIAL NUMBER: (B)(4)| ZIMMER SKIN GRAFT MESH CUTTERS: