BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNISPAN MENISCAL FASTERNER, 0 DEGREE NEEDLE

    MDR report key: 2003728 · Received February 23, 2011

    Report

    Report Number
    1221934-2011-00065
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 15, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    UNK
    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 AN ARTHROSCOPIC MENISCAL REPAIR ON A (B)(6), THE SURGEON EXPERIENCED A SERIES OF FAILURES THAT LED TO THE SURGEON PERFORMING A PARTIAL MENISCECTOMY FOR REMEDY. DURING THE ATTEMPTED REPAIR OF THE DAMAGED MENISCUS, THE SURGEON EMPLOYED THE OMNISPAN SYSTEM FOR FIXATION; THE SURGEON DEPLOYED THE 1ST FASTENER SUCCESSFULLY; HOWEVER, AT ATTEMPTING TO DEPLOY THE 2ND FASTENER, THE SPRING OF THE DEPLOYMENT GUN JAMMED OR WEDGED BETWEEN THE DEPLOYMENT NEEDLE AND THE FASTENER, CAUSING THE GUN TO MALFUNCTION; THE SURGEON WAS ABLE TO EASILY REMOVE THIS DEVICE FROM THE JOINT SPACE. THE SURGEON USED 2ND DEPLOYMENT GUN AND FASTENER TO CONTINUE ON; HOWEVER, THE EXACT SAME THING HAPPENED AGAIN. THE SURGEON RESORTED TO A 3RD DEPLOYMENT GUN AND FASTENER, AND AGAIN, THE EXACT SAME EXPERIENCE OCCURRED. AT THIS POINT IN TIME, THE SURGEON DECIDED TO CONTINUE ON USING A COMPETITOR'S DEVICE (FAST FIX), AND AGAIN THE SURGEON EXPERIENCED FAILURE. THE SURGEON DECIDED TO ABANDON ANY ATTEMPT AT FIXATING THE MENISCAL TEAR AND TURNED TO PERFORMING A PARTIAL MENISCECTOMY FOR THE REMEDY WITHOUT FURTHER ISSUE OR HARM TO THE PT. ALL OF THE COMPLAINT DEVICES WERE DISCARDED AT THE USER FACILITY. ALSO SEE ASSOCIATED MDRS 1221934-2011-00061, 1221934-2011-00062, 1221934-2011-00063, -1221934-201100064 AND 1221934-2011-00066.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISPAN MENISCAL FASTERNER, 0 DEGREE NEEDLE MENISCAL FASTENER MBI DEPUY MITEK 228140 3466562

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention