BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCS ANCHORS

    MDR report key: 291033 · Received August 17, 2000

    Report

    Report Number
    1221934-2000-00030
    Event Type
    Injury
    Date Received
    August 17, 2000
    Date of Event
    July 12, 2000
    Report Date
    July 18, 2000
    Manufacturer
    MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER COMPLAINTS OF PINCHING IN THE SHOULDER AND X-RAY REVEALED THAT ONE OF THE ARCS OF THE KNOTLESS ANCHOR HAD DETACHED AND WAS FLOATING IN THE JOINT. UNDER ARTHROSCOPIC VISUALIZATION IT WAS DETERMINED THAT THE PAIN WAS BEING CAUSED BY THE ANCHOR SITTING PROUD AND ABRADING THE ARTICULAR SURFACE OF THE HUMERAL HEAD. THE KNOTLESS ANCHOR WAS REMOVED USING GRASPERS. THE INITIAL BANKART REPAIR WAS SUCCESSFUL AND NO ADD'L REPAIRS WERE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCS ANCHORS KNOTLESS SUTURE ANCHOR MBI MITEK 212029 990705

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention