BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN MENISCAL FASTENER; 12 DEGREE NEEDLE

    MDR report key: 2002432 · Received January 28, 2011

    Report

    Report Number
    1221934-2011-00038
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 17, 2011
    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 AND THE 2ND FASTENER OF AN OMNISPAN MENISCAL FASTENERS FELL OFF OF THE FASTENER INTO THE PT'S JOINT SPACE. THE SURGEON HAD JUST DEPLOYED THE 1 FASTENER AND WAS PULLING THE INSERTER NEEDLE BACK, AT THIS POINT; THE SLEEVE CAME OFF OF THE INSERTER NEEDLE BRINGING THE 2ND FASTENER WITH IT. BOTH THE TUBING AND THE FASTENER WERE RETRIEVED FROM THE BODY; HOWEVER, THE SURGEON DID NOT WANT TO CAUSE ANY DAMAGE TO THE MENISCUS AND COMPLETED THE PROCEDURE WITH THE 1 FASTENER 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 3475064

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR