BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    125° RADIOLUCENT TARGETING ARM

    MDR report key: 24036029 · Received January 12, 2026

    Report

    Report Number
    1220246-2026-00134
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 22, 2025
    Report Date
    February 16, 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 THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED 1267-100 BATCH 210921 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A CRACK AT THE CONNECTION WITH THE METAL AND REGULAR SIGNS OF WEAR AND TEAR. A FUNCTIONAL TEST WAS PERFORMED BY PRESSING THE BUTTONS; FRICTION WAS NOTED, WHICH COULD BE DUE TO CONTINUOUS REPROCESSING. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND TEAR ON THE 2021-MANUFACTURED DEVICE.

    Description of Event or Problem · 0

    ON 22-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1267-100 RADIOLUCENT TARGETING ARM CRACKED AT THE METAL INTERFACE ATTACHING TO THE NAIL DURING IMPACTING OF THE IMPACTOR PAD. THIS WAS DISCOVERED DURING A TROCHANTERIC NAIL PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98895 125° RADIOLUCENT TARGETING ARM ORTHOPEDIC MANUAL SURG INSTR HSB ARTHREX, INC. 125° RADIOLUCENT TARGETING ARM 210921 00848665028652

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown