BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROACH, PEGGED GLENOID

    MDR report key: 19764007 · Received July 17, 2024

    Report

    Report Number
    1220246-2024-06799
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867059443
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED, AR-9233, GUIDE BROACH, BATCH 121508, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE ANVIL WAS BROKEN OFF ON THE DISTAL END AND WAS NOT RETURNED FOR INVESTIGATION. ADDITIONALLY, SIGNS OF WEAR AND TEAR WERE VISIBLE THROUGHOUT THE DEVICE: THE LASER MARKS WERE FADED, DISCOLORATION, OXIDATION AND STRIKE MARKS. THE MOST LIKELY CAUSE IS ATTRIBUTED TO WEAR AND TEAR DUE TO REPEATED USE OF THE DEVICE.

    Description of Event or Problem · 0

    ON 06/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS- (B)(4) THAT AN AR-9233 GUIDE BROACH BACK CAP SHEARED FROM INNER SLEEVE. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 7/2/2024: THIS EVENT OCCURRED WHILE INSIDE THE PATIENT, AND ALL FRAGMENTS WERE RETRIEVED. THE SURGEON HAD ALREADY BROACHED ENOUGH, AND THE INSTRUMENT WAS BROKEN UPON FINAL IMPACTION, SO IT BROKE RIGHT WHEN THEY FINISHED WITH THE AR-9233 GUIDE BROACH. THIS WAS DISCOVERED DURING A TOTAL SHOULDER ARTHROPLASTY (ECLIPSE/VAULTLOCK) PROCEDURE ON (B)(6)2024. THERE WAS NO DELAY IN THE CASE, AND IT WAS COMPLETED SUCCESSFULLY. PHOTOS ARE ATTACHED OF THE COMPLAINT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359032 BROACH, PEGGED GLENOID MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. BROACH, PEGGED GLENOID UNK 00888867059443

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown