BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNOTILUS ANCHOR, 3.5MM

    MDR report key: 6968296 · Received October 23, 2017

    Report

    Report Number
    8043971-2017-00005
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    August 15, 2017
    Report Date
    August 15, 2017
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION LTD
    Product Code
    MBI
    UDI-DI
    10810190010003
    PMA / PMN Number
    K113297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PATELLA STABILIZATION, TWO KNOTILUS ANCHORS FAILED. THE SUTURE DID NOT SEAT PROPERLY IN THE FIRST ANCHOR. THIS ANCHOR WAS REMOVED BY DRILLING IT OUT. THEN, THE SAME HOLE WAS USED FOR THE SECOND ANCHOR. HOWEVER, UPON TENSIONING OF THE SUTURE, THE ANCHOR PULLED OUT. IT WAS NOTICED THAT ONE OF THE TEETH HAD BROKEN OFF. THE WHOLE ANCHOR WAS REMOVED FROM THE JOINT. THERE WAS A DELAY OF LESS THAN 5 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747693 KNOTILUS ANCHOR, 3.5MM KNOTILUS ANCHOR, 3.5MM MBI T.A.G. MEDICAL PRODUCTS CORPORATION LTD 3910-500-100 16M06 10810190010003

    Patients

    Seq Age Sex Outcome Treatment
    1