BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130° RADIOLUCENT TARGETING ARM

    MDR report key: 21663771 · Received March 21, 2025

    Report

    Report Number
    1220246-2025-01104
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    February 26, 2025
    Report Date
    July 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

    ADDITIONAL INFORMATION: B3, B5, H3, H6.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS NOT CONFIRMED. ONE UNPACKAGED 1268-100 130° RADIOLUCENT TARGETING ARM BATCH NUMBER: 212054 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED SUPERFICIAL WEAR AND TEAR TO THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED BY ASSEMBLING THE RETURNED DEVICE WITH KNOWN GOOD MATING PARTS AND IT WAS FOUND THAT THE RETURNED DEVICE WAS ABLE TO TARGET AND ALIGN WITH THE DISTAL STATIC CORTICAL SCREW HOLE AS INTENDED. NO PROBLEM FOUND. 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

    ADDITIONAL INFORMATION WAS RECEIVED ON 03/12/2025: THIS OCCURRED AT THE END OF THE CASE DURING A TROCH FX PROCEDURE ON (B)(6) 2025. THEY USED ANOTHER 1268-100 130° RADIOLUCENT TARGETING ARM AND A DIFFERENT HOLE TO COMPLETE THE CASE. THEY USED A DYNAMIC HOLE, NOT A STATIC ONE, TO COMPLETE THE CASE. THERE WAS NO CASE DELAY. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.

    Description of Event or Problem · 0

    ON 03/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1268-100 130° RADIOLUCENT TARGETING ARM WOULD NOT TARGET THE DISTAL STATIC CORTICAL SCREW HOLE. THE CASE WAS COMPLETED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620529 130° RADIOLUCENT TARGETING ARM ORTHOPEDIC MANUAL SURG INSTR HSB ARTHREX, INC. 130° RADIOLUCENT TARGETING ARM 212054 00848665028645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown