BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN

    MDR report key: 1733212 · Received June 14, 2010

    Report

    Report Number
    1221934-2010-00217
    Event Type
    Malfunction
    Date Received
    June 14, 2010
    Report Date
    May 4, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ON A LIMITED LAUNCH; THE DEVELOPMENT AND QUALITY TEAMS ARE MONITORING THIS PRODUCT. THIS PARTICULAR INSTANCE WAS DRIVEN BY AN EXCESSIVE FAT PAD THAT THE TUBING CAUGHT ON; THERE WERE NO PATIENT CONSEQUENCES OR HARM. THIS COMPLAINT ESTABLISHED TO CAPTURE AND TREND. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    DURING A MENISCAL REPAIR, THE SILICONE TUBE OF ONE OF THE 3 OMNISPAN FASTENERS USED FOR FIXATION CAME OFF OF THE NEEDLE AS THEY WERE REMOVING THE APPLIER FROM THE PORTAL AND FELL INTO THE JOINT SPACE. THE DEVICE WAS EASILY RETRIEVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISPAN MENISCAL FASTENER MBI DEPUY MITEK 228141 3400971

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK