BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II DERMATOME WITH RATCHET

    MDR report key: 1993827 · Received January 13, 2011

    Report

    Report Number
    1526350-2011-00010
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. THE SERVICE RECORD INDICATES THE DEVICE IS 20 YEARS OLD AND HAS NOT BEEN RETURNED TO ZIMMER SURGICAL FOR REGULAR PREVENTATIVE MAINTENANCE. A VISUAL INSPECTION FOUND THE CALIBRATION OUT OF SPECIFICATION AND MECHANICAL DAMAGE TO THE DEVICE. THE CAUSE OF THE REPORTED ISSUE IS DUE TO THE DEVICE CONDITION AND LACK OF PREVENTIVE MAINTENANCE. THE IFU STATES THE DEVICE SHOULD BE RETURNED EVERY 12 MONTHS FOR INSPECTION AND PREVENTIVE MAINTENANCE. 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 THE SKIN PROPERLY. ADDITIONAL CLINICAL INFO RECEIVED ON (B)(6) 2010 INDICATED THAT THE UNIT DID NOT PERFORATE THE SKIN WELL/ HOLES WERE NOT "STEADY". THE GRAFT WAS USABLE AND NO ADDITIONAL GRAFT HARVEST WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESHGRAFT II DERMATOME WITH RATCHET MESHGRAFT II DERMATOME WITH RATCHET GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1