BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN MENISCAL FASTENER, 12 DEGREE NEEDLE

    MDR report key: 1970013 · Received January 14, 2011

    Report

    Report Number
    1221934-2011-00020
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 20, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A F/U REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR, THE SILICONE RETENTION TUBE OF AN OMNISPAN MENISCAL FASTENERS FELL OFF OF THE FASTENER INTO THE PT'S JOINT SPACE. THE TUBING WAS EASILY RETRIEVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. THE COMPLAINT DEVICE WAS 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK