BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3597708 · Received November 22, 2013

    Report

    Report Number
    1526350-2013-00702
    Event Type
    Malfunction
    Date Received
    November 22, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 13, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING MAY 31, 2012, U.S. AND CANADA CUSTOMERS WERE SENT AN URGENT PT SAFETY ADVISORY INFORMING THEM THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THE ZIMMER SKIN GRAFT MESHER. CUSTOMER WERE INFORMED THAT IMPROPERLY MAINTAINED INSTRUMENTS MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. CUSTOMERS WERE REQUESTED TO CONTACT ZIMMER TO SCHEDULE MAINTENANCE FOR THE DEVICE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 12/15/1992 AND WAS LAST REPAIRED ON (B)(4) 2012 FOR A NON-RELATED ISSUE. EVAL OF THE DEVICE OBSERVED A COMPLETELY SHEARED AND BENT RIGHT TIME ON THE COMB, AS WELL AS A BENT REAR LIP ON THE COMB. WEAR TO BOTH THE RIGHT END OF THE ROLLER AND ROLLER GEAR WAS ALSO OBSERVED PRIOR TO REPAIR, A TEST MESH AND CALIBRATION CHECK COULD NOT BE PERFORMED DUE TO THE DAMAGED COMB. CUSTOMER DID NOT RETURN A RATCHET OR CUTTERS FOR EVAL. THE CAUSE IS LIKELY THE USER NOT MAINTAINING THE DEVICE PER PROPER HANDLING AND LACK OF PREVENTATIVE MAINTENANCE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMB OF THE ZIMMER SKIN GRAFT MESHER WAS BENT. NO ADDITIONAL CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL CLINICAL INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611099 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1