BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS II VER ROD BRACKET FOR BROACH

    MDR report key: 18430321 · Received January 2, 2024

    Report

    Report Number
    1220246-2024-00017
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    November 28, 2023
    Report Date
    January 13, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867137967
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. COMPLAINT ALLEGATION IS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THIS FAILURE IS ATTRIBUTED TO WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE. MANUFACTURED DATE 2018.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 12/4/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9231-20 UNIVERS II VERSION ROD BRACKET FOR BROACH COLD WELDED IN THE CLIP AND BROKE OFF, AND CRESTED JAGGED METAL GOT STUCK. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME ON (B)(6) 2023, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559044 UNIVERS II VER ROD BRACKET FOR BROACH ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. UNIVERS II VER ROD BRACKET FOR BROACH 011830 00888867137967

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown