BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX INSERTION DEVICE FOR ARTHREX KNOTLESS FIBERTAK (2.6 FRENCH) SOFT ANCHOR

    MDR report key: 18066499 · Received November 2, 2023

    Report

    Report Number
    MW5147743
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    September 29, 2023
    Report Date
    October 19, 2023
    Manufacturer
    ARTHREX INC.
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE PROCEDURE (RIGHT ELBOW OPEN REPAIR OF LATERAL ULNAR COLLATERAL LIGAMENT AND RIGHT ELBOW ULNAR COLLATERAL LIGAMENT RECONSTRUCTION WITH PALMARIS LONGUS AUTOGRAFT WITH INTERNAL BRACE) A SMALL METALLIC FRAGMENT OF ANCHOR INSERTION DEVICE IMBEDDED INTO THE ULNA AT THE SUBLIME TUBERCLE. FOREIGN BODY UNABLE TO BE REMOVED WITHOUT CAUSING PATIENT HARM OR INJURY, THEREFORE, IT WAS INTENTIONALLY RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952183 ARTHREX INSERTION DEVICE FOR ARTHREX KNOTLESS FIBERTAK (2.6 FRENCH) SOFT ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHREX INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Other