BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN 0 DEGREE MENISCAL FASTENER

    MDR report key: 1885053 · Received October 20, 2010

    Report

    Report Number
    1221934-2010-00390
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 19, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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, THE SILICONE RETAINING SHEATH OF AN OMNISPAN MENISCAL FASTENER FELL OFF AND INTO THE PATIENT'S JOINT SPACE. THE FRAGMENT WAS EASILY RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISPAN 0 DEGREE MENISCAL FASTENER MENISCAL FASTENER MBI DEPUY MITEK 228140 3400972

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK