BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS REVERS VERSION ROD

    MDR report key: 21018699 · Received December 26, 2024

    Report

    Report Number
    1220246-2024-09051
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    November 21, 2024
    Report Date
    July 10, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867061620
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. 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 FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO MISALIGNED INSERTION.

    Description of Event or Problem · 0

    ON 11/29/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9510-01 ARTHREX UNIVERS REVERS¿ VERSION ROD AND AN AR-9216-4 GLENOID REAMER/DRILL GLOVE PROTECTOR BROKE DURING USE. THE CASE WAS COMPLETED SUCCESSFULLY. NO PIECES BROKE OFF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718959 UNIVERS REVERS VERSION ROD ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. UNIVERS REVERS VERSION ROD UNK 00888867061620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown