BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130° RADIOLUCENT TARGETING ARM

    MDR report key: 23212707 · Received October 3, 2025

    Report

    Report Number
    1220246-2025-04401
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 23, 2025
    Report Date
    December 16, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    PMA / PMN Number
    K021008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. ONE UNPACKAGED 1268-100 RADIOLUCENT TARGETING ARM, 130° TROCH NAIL, BATCH 221229, WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE SCREW SECURING THE IMPACTOR PAD HAD BECOME DETACHED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DEVICE'S DAMAGE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND TEAR RESULTING FROM REPEATED USE. COMPLAINT ALLEGATION IS CONFIRMED. REFER TO THE INVESTIGATION PHOTOS.

    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 (B)(6) 2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT THE THREADED COLLAR FOR THE 0826-000 IMPACTOR PAD BECAME UNSCREWED FROM THE 1268-100 TARGETING ARM ALONG WITH THE IMPACTOR PAD, AND NOW THEY¿RE STUCK TOGETHER. THIS OCCURRED DURING A TROCHANTERIC NAIL PLACEMENT PROCEDURE WITH NO PATIENT HARM. DEBRIS WAS CREATED, BUT THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2196354 130° RADIOLUCENT TARGETING ARM ORTHOPEDIC MANUAL SURG INSTR HSB ARTHREX, INC. 130° RADIOLUCENT TARGETING ARM 221229

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown