BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130° RADIOLUCENT TARGETING ARM

    MDR report key: 21445458 · Received February 24, 2025

    Report

    Report Number
    1220246-2025-00610
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    February 10, 2025
    Report Date
    June 2, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665028645
    PMA / PMN Number
    K021008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED 1268-100 RADIOLUCENT TARGETING ARM BATCH NUMBER: 220993 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED THAT THE GREEN BUTTON WAS NO LONGER ATTACHED TO THE DEVICE AND WAS MISSING. FURTHER VISUAL EVALUATION NOTED THE INTERNAL COMPONENT FOR THE BUTTONS WAS LOOSE. FUNCTIONAL TESTING WAS NOT ABLE TO BE PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO OVERSTRESSING A DEVICE THAT IS DAMAGED NATURALLY AND INEVITABLY AS A RESULT OF NORMAL WEAR OR AGING FROM REPEATED USAGE/REPROCESSING. MANUFACTURED DATE: 08-DEC-2022. REFER TO 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 02/10/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT A 1268-100 RADIOLUCENT TARGETING ARMS GREEN PLASTIC PUSH BUTTON POPPED OUT AND LANDED ON THE FLOOR. THIS OCCURRED DURING A PROCEDURE. ONCE THEY BEGAN TO INSERT THE NAIL OVER THE BALL NOSE GUIDE WIRE, THE SURGEON MALLETED THE IMPACTOR PAD TO ADVANCE THE NAIL. ON HIS FIRST STRIKE, THE GREEN PLASTIC PUSH BUTTON POPPED OUT AND LANDED ON THE FLOOR. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH NO ISSUES, AND THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613027 130° RADIOLUCENT TARGETING ARM ORTHOPEDIC MANUAL SURG INSTR HSB ARTHREX, INC. 130° RADIOLUCENT TARGETING ARM 220993 00848665028645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown