BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    125° RADIOLUCENT TARGETING ARM

    MDR report key: 23943544 · Received January 2, 2026

    Report

    Report Number
    1220246-2026-00011
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    December 11, 2025
    Report Date
    February 12, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665028652
    PMA / PMN Number
    K021008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: D9, G3, H3, H6. ONE UNPACKAGED 1267-100 RADIOLUCENT TARGETING ARM (BATCH 212569) WAS RECEIVED FOR INVESTIGATION. THE DEVICE ARRIVED WITH AN 0826-000 IMPACTOR PAD ATTACHED. VISUAL INSPECTION NOTED THAT THE 0826-000 IMPACTOR PAD WAS STUCK TO THE GROMMET OF THE 1267-100 RADIOLUCENT TARGETING ARM AND COULD NOT BE DETACHED. FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICES WERE INSEPARABLE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS ATTRIBUTED TO USE-RELATED FACTORS, INCLUDING WEAR-AND-TEAR DAMAGE AND EXCESSIVE MECHANICAL FORCES APPLIED TO THE IMPACTOR PAD IN THE FIELD OVER TIME. THE MANUFACTURING DATE FOR THE TARGETING ARM IS NOVEMBER 2021. REFER TO THE INVESTIGATION PHOTOS. THE COMPLAINT ALLEGATION IS CONFIRMED.

    Description of Event or Problem · 0

    ON 11-DEC-2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT A 1267-100 125-DEGREE RADIOLUCENT TARGETING ARM BROKE WHILE THE SURGEON WAS TRYING TO REMOVE THE IMPACTOR PAD TO GET BETTER VISUALIZATION ON THE LATERAL X-RAY TO VERIFY PIN PLACEMENT DURING A CASE. THERE WERE NO ADVERSE EVENTS, AND THE CASE WAS FINISHED WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9525 125° RADIOLUCENT TARGETING ARM ORTHOPEDIC MANUAL SURG INSTR HSB ARTHREX, INC. 125° RADIOLUCENT TARGETING ARM 212569 00848665028652

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown