BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN 12 DEGREE MENISCAL FASTENER

    MDR report key: 2122262 · Received June 13, 2011

    Report

    Report Number
    1221934-2011-00236
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 9, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    K092836
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 WITH THE USE OF 9 VARIOUS DEGREE OMNISPANS FOR FASTENING, 2 OF THE NINE DEVICES; A 0 DEGREE AND A 12 DEGREE NEEDLE, HAD THE SILICONE RETENTION TUBING COME OFF OF THE INSERTER NEEDLE AND INTO THE PATIENT'S JOINT SPACE, POSSIBLY DUE TO OVER-PENETRATION. THE SURGEON WAS ABLE TO RETRIEVE BOTH OF THE SILICONE TUBINGS, AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. COMPLAINT DEVICES DISCARDED AT USER FACILITY. ALSO SEE ASSOCIATED MDR 1221934-2011-00235.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISPAN 12 DEGREE MENISCAL FASTENER MENISCAL FASTENER MBI DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1