BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130° RADIOLUCENT TARGETING ARM

    MDR report key: 23062698 · Received September 16, 2025

    Report

    Report Number
    1220246-2025-03877
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 26, 2025
    Report Date
    November 3, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665028645
    PMA / PMN Number
    K021008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED 1268-100, BATCH NUMBER 210929, WAS RECEIVED FOR EVALUATION. VISUAL EVALUATION: THE INSPECTION REVEALED THAT THE THREADED CONNECTOR FROM BATCH 1268-100 (LOT 210929) WAS COLD-WELDED TO PART 0826-000, BATCH 211082. A HOLE WAS LEFT WHERE THE CONNECTOR HAD BEEN POSITIONED. FUNCTIONAL TESTING: ATTEMPTED FUNCTIONAL TESTING COULD NOT BE COMPLETED DUE TO THE COLD-WELDED THREADS BETWEEN PART 1268-100 (BATCH 210929) AND PART 0826-000 (BATCH 211082). THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE. THE DEVICE WAS MANUFACTURED IN 2021.

    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 08/26/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT A COLD-WELDED JIG OF AN 0826-000 IMPACTOR PAD AND 1268-100 130-DEGREE TARGETING ARM BROKE OUTSIDE OF THE PATIENT DURING A TROCH NAIL PROCEDURE. NO PATIENT WAS AFFECTED. THE PROCEDURE WAS COMPLETED AS NORMAL, AND THE IMPACTOR WAS TAKEN OFF AT THE END. ADDITIONAL INFORMATION RECEIVED ON 9/8/2025 FROM SALES REP: IT WAS REPORTED THAT THE BREAK OCCURRED OUTSIDE OF THE PATIENT. NO FRAGMENTS WERE PRODUCED. THIS OCCURRED DURING A TROCH NAIL PROCEDURE AND WAS COMPLETED AS NORMAL AS THE IMPACTOR WAS JUST TAKEN OFF AT THE END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2673703 130° RADIOLUCENT TARGETING ARM ORTHOPEDIC MANUAL SURG INSTR HSB ARTHREX, INC. 130° RADIOLUCENT TARGETING ARM 210929 00848665028645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown