BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130° RADIOLUCENT TARGETING ARM

    MDR report key: 21143245 · Received January 13, 2025

    Report

    Report Number
    1220246-2025-09401
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 18, 2024
    Report Date
    February 14, 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

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED 1268-100 RADIOLUCENT TARGETING ARM, 130 DEGREE TROCH NAIL BATCH NUMBER 210930 WAS RECEIVED FOR INVESTIGATION. A VISUAL INSPECTION REVEALED SIGNS OF WEAR ON THE DEVICE¿S MATERIAL. FUNCTIONAL TESTING WAS PERFORMED WITH A KNOWN GOOD DEVICE, AND A SLIGHT MISALIGNMENT WITH THE LAG SCREW WAS NOTED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND TEAR OF THE DEVICE. MANUFACTURING DATE: SEPTEMBER 03, 2021.

    Description of Event or Problem · 0

    ON 12/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN 1268-100 TARGETING ARM IS MALFUNCTIONING. THE NAIL AND LAG SCREW WERE NOT ALIGNING ON THE JIG. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486304 130° RADIOLUCENT TARGETING ARM ORTHOPEDIC MANUAL SURG INSTR HSB ARTHREX, INC. 130° RADIOLUCENT TARGETING ARM 210930 00848665028645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown