BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II COMPLETE

    MDR report key: 3140142 · Received May 29, 2013

    Report

    Report Number
    1526350-2013-00270
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING 05/31/2012, US AND (B)(4) CUSTOMERS WERE SENT AN URGENT PATIENT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR ZIMMER MESHGRAFT II COMPLETE. 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 01/02/2009 AND HAD NO REPAIRED HISTORY AT ZIMMER SURGICAL. EVALUATION OF THE DEVICE OBSERVED THAT THE CUTTER AND ROLLER WERE WORN. IT WAS ALSO OBSERVED THAT THE SIDE PLATES WERE WORN. PRIOR TO REPAIR, THE DEVICE WAS WITHIN CALIBRATION SPECIFICATION AND THE DEVICE 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 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 PROPERLY. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE REPORTED ISSUE WAS NOTICED WHILE PRODUCING A TEST MESH DURING SET-UP AND THERE WAS NO IMPACT TO THE PATIENT. AN ALTERNATE DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE AND THERE WAS NO INCREASE IN SURGICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235004 MESHGRAFT II COMPLETE MESHGRAFT II COMPLETE FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1