BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3241100 · Received July 18, 2013

    Report

    Report Number
    1526350-2013-00390
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING 05/31/2002, US AND (B)(4) CUSTOMERS WERE SENT AN URGENT PT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR ZIMMER SKIN GRAFT MESHER. CUSTOMERS 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 MFR FOR REPAIR AND EVALUATION. THE SVC RECORD INDICATES THAT THE DEVICE WAS MFG ON 06/29/1998 AND WAS LAST REPAIRED ON 10/13/2010. EVALUATION OF THE DEVICE OBSERVED THAT THE RATCHET WAS MISSING THE RATCHET GEAR AND SPRINGS. IT WAS ALSO OBSERVED THAT THE SIDE PLATES, COMB, ROLLER AND GEAR WERE DAMAGED. PRIOR TO REPAIR, THE DEVICE COULD NOT BE CHECKED DUE TO THE DAMAGE TO THE COMB. EVALUATION OF THE 1.5:1 CUTTER DETERMINED THAT IT PRODUCED AN UNACCEPTABLE TEST MESH. THE CAUSE IS MOST LIKELY DUE TO THE USER NOT MAINTAINING THE DEVICE PER PREVENTIVE MAINTENANCE AND HANDLING. ACCORDING TO THE INSTRUCTIONS FOR USE. THE ZIMMER SKIN GRAFT MESHER SHOULD BE RETURNED EVERY 12 MONTHS FOR INSPECTION AND PREVENTIVE MAINTENANCE. ANNUAL FACTORY CALIBRATION CHECKS ARE STRONGLY RECOMMENDED TO VERIFY CONTINUED ACCURACY. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE ZIMMER SKIN GRAFT MESHER WAS BENT AND THE HANDLE WAS BROKEN. DURING DEVICE ANALYSIS, IT WAS DETERMINED THAT THE COMB WAS BENT. NO ADD'L CLINICAL INFORMATION WAS AVAILABLE REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335778 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00-7703-015-00, SERIAL NUMBER (B)(4)| ZIMMER SKING GRAFT MESHER CUTTER 1.5:1