BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II WITH RATCHET

    MDR report key: 3237891 · Received July 17, 2013

    Report

    Report Number
    1526350-2013-00385
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING MAY 31, 2012, US AND (B)(6) CUSTOMERS WERE SENT AN URGENT PATIENT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR ZIMMER MESHGRAFT II. 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 MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 06/23/1978 AND WAS LAST REPAIRED ON 02/12/1993, FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED THAT THE RATCHET GEAR, SLIDING PIN AND SPRING WERE DISCOLORED. IT WAS ALSO OBSERVED THAT THE DEVICE HAD OLD STYLE SIDE PLATES. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE OF CALIBRATION SPECIFICATIONS. OBSERVATION OF THE RETURNED CUTTER IDENTIFIED MULTIPLE NICKS. A TEST MESH USING THE DEVICE AND RETURNED CUTTER PRODUCED AN UNACCEPTABLE MESH. THE CAUSE IS LIKELY THE USER NOT MAINTAINING THE DEVICE PER LACK OF PREVENTATIVE MAINTENANCE AND THE DEVICE EXCEEDING USEFUL LIFE. THE MESHGRAFT II TISSUE EXPANSION SYSTEM 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 MESHGRAFT II WAS NOT CUTTING WELL. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE MESHER WAS NOT SHARP ENOUGH TO CUT AND WOULD NOT PULL THE SKIN THROUGH THE DEVICE. THE SURGEON WAS ABLE TO USE A BLADE TO PREPARE THE GRAFT AND THE HARVESTED GRAFT WAS ABLE TO BE USED. NO ADDITIONAL UNPLANNED GRAFT HARVEST WAS REQUIRED. THERE WAS NO PATIENT INJURY, SURGICAL DELAY OR INCREASE IN SURGICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332755 MESHGRAFT II WITH RATCHET MESHGRAFT II WITH RATCHET FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1