BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOID TARGETER HANDLE

    MDR report key: 21662875 · Received March 21, 2025

    Report

    Report Number
    1220246-2025-01092
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    March 3, 2025
    Report Date
    August 7, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867315341
    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: B5, D9, G3, H3, H6. ONE UNPACKAGED AR-5400-02 VIP¿ GLENOID TARGETER, HANDLE BATCH NUMBER: 052317, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED DISCOLORATION AND DAMAGE TO THE THREADS, WHICH IS LIKELY RELATED TO THE COMPLAINT ALLEGATION. FUNCTIONAL TESTING OF THE DEVICE WITH A KNOWN GOOD DEVICE NOTED THAT THE DEVICE DID NOT MATE SECURELY. 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. THE MANUFACTURING DATE IS IN DECEMBER 2023. REFER TO INVESTIGATION PHOTOS. COMPLAINT ALLEGATION IS 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

    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.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369247 GLENOID TARGETER HANDLE ORTHOPEDIC MANUAL SURG INSTR KWS ARTHREX, INC. GLENOID TARGETER HANDLE 052317 00888867315341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown