BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL, MEDIUM, PEGGED GLENOID

    MDR report key: 17248124 · Received July 3, 2023

    Report

    Report Number
    1220246-2023-07039
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    June 7, 2023
    Report Date
    October 21, 2024
    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

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT HAS NOT YET BEEN DETERMINED AS THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED, INCLUDING A MOST LIKELY CAUSE IF A ROOT CAUSE CAN NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    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 USER-APPLIED MECHANICAL FORCES DURING INSERTION/EXTRACTION OF THE TRIAL.

    Description of Event or Problem · 0

    ON 06/07/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-02 TRIAL BROKE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED ON 6/14/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26619 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