BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL, MEDIUM, PEGGED GLENOID

    MDR report key: 19240198 · Received May 3, 2024

    Report

    Report Number
    1220246-2024-02776
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 11, 2024
    Report Date
    April 24, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWT
    UDI-DI
    00888867059481
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    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.

    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 OF THE REPORTED FAILURE IS WEAR AND TEAR. DUE TO CONTINUOUS MECHANICAL FORCES APPLIED TO IT, THE DEVICE WILL INEVITABLY SUSTAIN DAMAGE OVER TIME.

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-9236-02 GLENOID TRIAL CENTRAL PEG BROKE OFF IN THE PATIENT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ALL FRAGMENTS WERE REMOVED. DELAY IN CASE 20 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810838 TRIAL, MEDIUM, PEGGED GLENOID ORTHOPEDIC MANUAL SURG INSTR HWT ARTHREX, INC. TRIAL, MEDIUM, PEGGED GLENOID UNK 00888867059481

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown