BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNISPAN MENISCAL FASTENER, 12 DEGREES

    MDR report key: 1893045 · Received October 28, 2010

    Report

    Report Number
    1221934-2010-00395
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS, AT THIS POINT IN TIME, IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR PROCEDURE, 2 OMNISPAN MENISCAL FASTENERS FAILED TO FIXATE, AND ONE OF THE DEVICES' SILICONE RETAINING SLEEVES CAME OFF AND FELL INTO THE PT'S JOINT SPACE; WAS EASILY RETRIEVED WITHOUT ISSUE. AT THIS POINT, THE SURGEON CHOSE TO PERFORM A PARTIAL MENISECTOMY FOR REMEDY. THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. COMPLAINT DEVICES DISCARDED AT USER FACILITY. ALSO SEE ASSOCIATED MDR 1221934-2010-00394.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISPAN MENISCAL FASTENER, 12 DEGREES MENISCAL FASTENER MBI DEPUY MITEK 228141 3463944

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention