BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3136435 · Received May 23, 2013

    Report

    Report Number
    1526350-2013-00267
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(6) 2002, US AND (B)(6) 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 03/05/1992 AND WAS LAST REPAIRED ON (B)(6) 2011. EVALUATION OF THE DEVICE OBSERVED THAT THE COMB, SIDE PLATES, ROLLER AND RATCHET GEAR WERE DAMAGED. AT TEST MESH AND CALIBRATION COULD NOT BE PERFORMED DUE TO DAMAGE OF THE COMB. EVALUATION OF THE CUTTERS DETERMINED THAT THE 1.5:1, 2:1 AND 3:1 CUTTERS PRODUCED UNACCEPTABLE TEST MESHES. THE 4:1 CUTTER PRODUCED AN ACCEPTABLE 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 REPORTED THAT THE ZIMMER SKIN GRAFT MESHER WAS TEARING SKIN. ADD'L CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THERE WAS NO IMPLICATION TO A PT OR EXTENDED SURGICAL TIME. THE HARVESTED GRAFT WAS USEABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227849 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00-7703-030-00, SN# (B)(4)| 00-7703-020-00, SN# (B)(4)| ZIMMER SKIN GRAFT MESHER CUTTERS:| 00-7703-015-00, SN# (B)(4)