BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNISPAN MENISCAL FASTENER, W/12 DEGREE NEEDLE

    MDR report key: 2080634 · Received April 25, 2011

    Report

    Report Number
    1221934-2011-00174
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 WITH THE USE OF OMNISPAN FOR MENISCAL FASTENING, BOTH FASTENERS FAILED TO DEPLOY PROPERLY: ALTHOUGH THE SURGEON'S TECHNIQUE WAS CORRECT, BOTH FASTENERS DELIVERED IN MID-SUBSTANCE OF THE MENISCAL TEAR. AT THIS POINT, THE SURGEON REMOVED THE FASTENERS FROM THE JOINT SPACE AND CHOSE TO PERFORM A PARTIAL MENISCECTOMY FOR REMEDY. THE PROCEDURE WAS CONCLUDED SUCCESSFULLY W/O FURTHER ISSUE OR HARM TO THE PT. THE COMPLAINT DEVICE DISCARDED AT THE USER FACILITY. ALSO, SEE ASSOCIATED MDRS 1221934-2011-00175 AND 1221934-2011-00176.

    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 3505898

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention