BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNISPAN MENISCAL FASTENER

    MDR report key: 1870217 · Received October 11, 2010

    Report

    Report Number
    1221934-2010-00355
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING A DIFFICULT ARTHROSCOPIC MENISCAL REPAIR PROCEDURE WITH THE USE OF 4 OMNISPAN FASTENER DEVICES ULTIMATELY RESULTED IN THE SURGEON PERFORMING A PARTIAL MENISECTOMY FOR REMEDY. IT APPEARS THAT THE PT'S KNEE JOINT SPACE WAS EXTREMELY TIGHT AND WAS PREVENTING EASY OR NORMAL TOOL ACCESS; SURGEON COULD NOT FIT A PROBE UNDER THE CONDYLE TO ACCESS THE MENISCAL AREA, EVEN WHEN THE KNEE WAS IN A NEUTRAL POSITION. IN THE ATTEMPT TO REPAIR THE PT'S MENISCAL TEAR WITH OMNISPAN MENISCAL FASTENERS, 4 DEVICES WERE NOT ABLE TO BE DEPLOYED TO ACCOMMODATE THE REPAIR. AT THIS POINT THE SURGEON RESORTED TO THE PARTIAL MENISECTOMY FOR REPAIR. SOME OF THE DEVICE'S BACKSTOP PORTIONS WERE LEFT IN THE JOINT SPACE; BALANCE OF DEVICES DISCARDED. ALSO SEE ASSOCIATED MDRS 1221934-2010-00356, 1221934-2010-00357 AND 1221934-2010-00358.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISPAN MENISCAL FASTENER MENISCAL FASTENER MBI DEPUY MITEK 228140 3412277

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention