BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN MENISCAL FASTENER, 12 DEGREE NEEDLE

    MDR report key: 2060825 · Received March 11, 2011

    Report

    Report Number
    1221934-2011-00109
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 7, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Product Problem
    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 REPRESENTATIVE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR, THE SILICONE FASTENER RETENTION TUBING OF AN OMNISPAN MENISCAL FASTENER CAME OFF INTO THE JOINT SPACE; THIS WAS EASILY RETRIEVED FROM THE BODY AND THE SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY USING A COMPETITORS DEVICE (ARTREX) WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. THE COMPLAINT DEVICE DISCARDED AT THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISPAN MENISCAL FASTENER, 12 DEGREE NEEDLE MENISCAL FASTENER MBI DEPUY MITEK 228141 3487226

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK