BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN MENISCAL FASTENER W/ 12 DEGREE NEEDLE

    MDR report key: 1922659 · Received November 12, 2010

    Report

    Report Number
    1221934-2010-00429
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 11, 2010
    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 REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR, THE SILICONE RETENTION TUBE OF TWO OMNISPAN MENISCAL FASTENERS FELL OFF OF THE FASTENERS INTO THE PATIENT'S JOINT SPACE. THE TUBINGS WERE EASILY RETRIEVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. THE COMPLAINT DEVICES WERE DISCARDED AT THE USER FACILITY. SEE ALSO ASSOCIATED MDR 1221934-2010-00430.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISPAN MENISCAL FASTENER W/ 12 DEGREE NEEDLE MENISCAL FASTENER MBI DEPUY MITEK 228141 3454947

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK