BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW DRIVER, HEX, 2.5MM

    MDR report key: 23583710 · Received November 18, 2025

    Report

    Report Number
    1220246-2025-05098
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    November 3, 2025
    Report Date
    February 10, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00888867524965
    PMA / PMN Number
    K050241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    ONE UNPACKAGED DRIVER, 0416-200, BATCH 220336, WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION REVEALED: SURFACE DAMAGE ON THE DEVICE BODY. THE TIP OF THE DEVICE WAS BROKEN. NO FRAGMENTS WERE RETURNED FOR EVALUATION. THE MOST LIKELY CAUSES OF THE REPORTED FAILURE MAY INCLUDE: IMPROPER BONE PREPARATION. MISALIGNED INSERTION. PRYING OR LEVERAGING THE DEVICE DURING INSERTION. THE COMPLAINT ALLEGATION IS CONFIRMED. REFER TO THE ATTACHED INVESTIGATION PHOTOS.

    Description of Event or Problem · 0

    ON 11/3/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 0416-200 SCREWDRIVER BROKE OFF WHILE THREADING THE LAST DISTAL SCREW INTO THE NAIL. IT WAS NOTICED WHEN TRYING TO ADJUST THE SCREW, ANOTHER DEVICE WAS BROUGHT IN, AND CASE COMPLETED WITH NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494732 SCREW DRIVER, HEX, 2.5MM ORTHOPEDIC MANUAL SURG INSTR HSB ARTHREX, INC. SCREW DRIVER, HEX, 2.5MM 220336 00888867524965

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown