BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESHGRAFT II DERMATOME WITH RATCHET

    MDR report key: 2031371 · Received March 23, 2011

    Report

    Report Number
    1526350-2011-00041
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. THE SERVICE RECORDS INDICATE THAT THE DEVICE HAS NOT BEEN IN FOR SERVICE SINCE 2005. THE INSPECTION FOUND THAT THE DEVICE DOES NOT ADVANCE THE CARRIER WHEN OPERATING THE RATCHET HANDLE, THE RATCHET SET SCREW WAS MISSING, AND THE DEVICE WAS OUT OF CALIBRATION. THE CAUSE OF THE REPORTED COMPLAINT WAS A WORN RATCHET GEAR, THE DEVICE WAS OUT OF CALIBRATION, AND THE CUTTER WAS DULL. THESE ARE INDICATIVE OF A LACK OF PREVENTATIVE MAINTENANCE. THE SKIN GRAFT (B)(4) IFU STATES: "THE ZIMMER SKIN GRAFT (B)(4) 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 MESHGRAFT II WAS MALFUNCTIONING. FURTHER INFORMATION RECEIVED THROUGH CLINICAL FOLLOW UP ON 02/22/2011 INDICATED THAT WHEN THE INITIALLY HARVESTED GRAFT WAS PUT THROUGH THE MESHGRAFT II, IT WAS "SHREDDED" AND UNUSABLE. A SECOND UNPLANNED GRAFT WAS HARVESTED AND MESHED WITH AN ADDITIONAL AVAILABLE ZIMMER MESHGRAFT II WITHOUT FURTHER ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1