BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX

    MDR report key: 16760851 · Received April 18, 2023

    Report

    Report Number
    16760851
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    March 28, 2023
    Report Date
    April 14, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867276901
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING LEFT SHOULDER ARTHROSCOPIC PROCEDURE, A 2.6MM ARTHREX FIBERTAK SUTURE ANCHOR (REF # AR-3632, LOT # 15036292, EXP. 11/30/2023), DOUBLE-LOADED WITH 1.3MM SUTURETAPE WAS USED. DURING THE PROCEDURE IT WAS NOTED THAT VERY TIP OF THE ANCHOR (APPROXIMATELY 1MM X 2MM IN SIZE) WAS MISSING AND HAD BROKEN OFF IN THE BONE. THE SURGEON INDICATED THAT THE TIP WAS APPROXIMATELY 1MM X 2MM IN SIZE) HAD BROKEN OFF IN THE BONE. THE SURGEON INDICATED THAT THE TIP WAS UNRETRIEVABLE AND DETERMINED THAT IT WOULD BE SAFER FOR THE PATIENT TO LEAVE THE TIP PIECE IN PLACE INSTEAD OF TRYING TO RETRIEVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187519 ARTHREX FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHREX, INC. AR-3632 15036292 00888867276901

    Patients

    Seq Age Sex Outcome Treatment
    1 20805 DA Male