BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOID TARGETER LOCKING NUT

    MDR report key: 21696800 · Received March 26, 2025

    Report

    Report Number
    1220246-2025-01134
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    March 3, 2025
    Report Date
    August 7, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867315365
    PMA / PMN Number
    K222007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. ONE UNPACKAGED AR-5400-04, BATCH NUMBER: 052317, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED DISCOLORATION AND DAMAGE TO THE THREADS. FUNCTIONAL TESTING OF THE DEVICE TO KNOWN GOOD AR-5400-02 FOUND NO ISSUES WITH THE THREADS, AND THE DEVICES WERE ABLE TO MATE SECURELY. NO PROBLEM FOUND. REFER TO INVESTIGATION PHOTOS. COMPLAINT ALLEGATION IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON 03/03/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-5400-02 VIP¿ GLENOID TARGETER HANDLE SLID EVEN THOUGH BOTH NUTS WERE SECURED TIGHTLY. AR-5400-04 VIP¿ GLENOID TARGETER LOCKING NUT, AND A SECOND NUT FROM THE AR-4500-S SET. THIS OCCURRED DURING A REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2025. ADDITIONAL INFORMATION WAS PROVIDED ON 03/04/2025 WHERE THE SALES REPRESENTATIVE STATED THE ARMS THAT DIDN¿T HOLD IN PLACE WERE 10,12,15,18,25. CLARIFICATION: IT WAS REPORTED THAT THE TARGETER ARMS, AR-5400-10, AR-5400-12, AR-5400-15, AR-5400-18, AND AR-5400-25 WERE SLIDING ON THE HANDLE, DESPITE BOTH NUTS BEING SECURELY TIGHTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093834 GLENOID TARGETER LOCKING NUT PROSTHESIS, SHOULDER, CEMENTED KWS ARTHREX, INC. GLENOID TARGETER LOCKING NUT 052317 00888867315365

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown