BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK OMNISPAN MENISCAL REPAIR SYSTEM W/ 27 DEGREE NEEDLE

    MDR report key: 3002451 · Received March 13, 2013

    Report

    Report Number
    1221934-2013-00059
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    K092836
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED, WHICH PRECLUDES CONDUCTING AN EVALUATION; HOWEVER, A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE, THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT TELL ANYTHING FROM THIS; WE CANNOT DISCERN A ROOT OR UNDERLYING CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. ALSO, 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

    OUR REP IS REPORTING THAT DURING A MENISCAL REPAIR WITH THE USE OF OMNISPAN FOR FASTENING, THE SURGEON NOTICED THAT THE 1ST OF THE 2 FASTENERS WAS MISSING FROM THE INSERTER NEEDLE. THIS WAS NOT NOTICED UPON LOADING IT ONTO THE APPLIER, BUT AFTER PENETRATION INTO THE JOINT SPACE. SO, IT IS NOT KNOWN IF THE DEVICE CAME THIS WAY, OR IF IT CAME OFF OF THE INSERTER NEEDLE WHILE IN THE BODY. THEY TOOK 2-3 MINUTES TO LOOK FOR THE POSSIBILITY OF THE DEVICE IN THE BODY; HOWEVER, THEY COULD NOT VERIFY ITS PRESENCE. THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. NOTHING BEING RETURNED, COMPLAINT DEVICE DISCARDED AT USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105052 MITEK OMNISPAN MENISCAL REPAIR SYSTEM W/ 27 DEGREE NEEDLE MENISCAL FASTENER MBI DEPUY MITEK NA 3539326

    Patients

    Seq Age Sex Outcome Treatment
    1