BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL, MEDIUM, PEGGED GLENOID

    MDR report key: 21303619 · Received February 4, 2025

    Report

    Report Number
    1220246-2025-00147
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    January 6, 2025
    Report Date
    September 4, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWT
    UDI-DI
    00888867059481
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. 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 CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR, INCLUDING APPLYING EXCESSIVE FORCE DURING USE. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED, AND NO EVIDENCE OF THE FAILURE WAS RECEIVED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-02 PEGGED GLENOID BROKE. THIS OCCURRED DURING USE UPON IMPACTION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61991 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