BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130° RADIOLUCENT TARGETING ARM

    MDR report key: 23325884 · Received October 17, 2025

    Report

    Report Number
    1220246-2025-04674
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    October 9, 2025
    Report Date
    February 2, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665028645
    PMA / PMN Number
    K021008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4, G3.

    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: B5, H3, H6.

    Additional Manufacturer Narrative · 0

    ONE UNPACKAGED 1268-100 130° RADIOLUCENT TARGETING ARM, BATCH NUMBER 210928, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED: DAMAGE TO THE THREADS OF THE DEVICE SURFACE DAMAGE AND FADING ALONG THE BODY. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. MOST LIKELY REASON FOR THE REPORTED FAILURE: MISALIGNMENT OF THE TARGETING ARM DURING SCREW INSERTION RESULTS IN AN INACCURATE TRAJECTORY. ADDITIONAL CONTRIBUTING FACTORS: MANIPULATION AND WIGGLING OF THE JIG DURING THE PROCEDURE MAY HAVE INCREASED MISALIGNMENT. POTENTIAL USER-RELATED FACTORS, SUCH AS THE TECHNIQUE DURING ASSEMBLY AND INSERTION. REFER TO THE INVESTIGATION PHOTOS. THE COMPLAINT ALLEGATION IS CONFIRMED.

    Description of Event or Problem · 0

    ON 10/10/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT A 1268-100 RADIOLUCENT TARGETING ARM, 130 DEGREE TROCH NAIL, EXPERIENCED AN ISSUE. THE ES SCREW TRAJECTORY WAS INACCURATE, CAUSING THE SCREW TO BIND WITHIN THE NAIL. THE SCREW CROSS-THREADED, AND THE SURGEON WAS UNABLE TO FULLY ADVANCE IT THROUGH THE NAIL. AS A RESULT, THE ES SCREW REMAINED PROMINENT ON THE LATERAL CORTEX OF THE FEMUR. THE CASE WAS COMPLETED SUCCESSFULLY AND NO PIECE BROKE OFF IN THE PATIENT. THIS WAS IDENTIFIED DURING A TROCHANTERIC NAIL PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED ON 10/17/2025: THE PRODUCT USED WITH THE NAIL WAS AR-9094ES-11-3930L ES TROCHANTERIC NAIL, LEFT. THE ISSUE OCCURRED DURING INSERTION OF THE ES SCREW. THE SURGICAL TEAM HAD TO MANIPULATE AND WIGGLE THE JIG IN ORDER TO INSERT THE SCREW. THE SAME ORIGINAL PART NUMBERS WERE USED TO COMPLETE THE CASE. THIS RESULTED IN A FIVE-MINUTE DELAY AND AN ADDITIONAL FIVE MINUTES OF ANESTHESIA ADMINISTRATION. NO PHOTOS WERE TAKEN FOR DOCUMENTATION, AND NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2864177 130° RADIOLUCENT TARGETING ARM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ARTHREX, INC. 130° RADIOLUCENT TARGETING ARM 210928 00848665028645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown