BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5X50MM BEVELED FT SCREW

    MDR report key: 24650155 · Received March 20, 2026

    Report

    Report Number
    1220246-2026-01568
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 20, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867360952
    PMA / PMN Number
    K210994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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.

    Description of Event or Problem · 0

    ON 02-MAR-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8741-40 T10 BEVELED HEXALOBE DRIVER SHAFT BROKE OFF INTO THE HEAD OF THE SCREW WHEN INSERTING INTO PATIENT DURING A METACARPAL FX PROCEDURE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED ON 04-MAR-2026. THE REP ADVISED THAT THE SURGEON USED A HANDLE (AR-8700RH) ATTACHED TO THE DRIVER SHAFT (AR-8741-40) TO INSERT THE SCREW BY HAND. THEY STATED THE SURGEON USED A 1.4MM GUIDE WIRE (AR-8741-14), AS WELL AS A 2.9MM DRILL BIT (AR-8741-25) TO PREP THE BONE FOR THE INSERTION OF THE SCREW. THE SURGEON WAS NOT ABLE TO USE THE DRIVER SHAFT (AR-8741-40) TO REMOVE THE SCREW SINCE THE DRIVER SHAFT BROKE OFF INTO THE HEAD OF THE SCREW (AR-8735BV-50). THEY WERE ABLE TO USE INSTRUMENTS THE HOSPITAL OWNED TO RETRIEVE THE REMAINING PIECES OF THE DRIVER SHAFT OUT OF THE HEAD OF THE SCREW. THEY THEN USED A DIFFERENT DRIVER SHAFT TO REMOVE THE SCREW (AR-8735BV-50), THEY RE-DRILLED WITH AN AR-8741-25, AND INSERTED AN AR-8735BV-48, WHICH WAS IMPLANTED USING A DIFFERENT DRIVER SHAFT. THE SURGEON USED THE 3.5MM BEVELED SCREWS, IMPLANTED/EXPLANTED AR-8735BV-50, AND IMPLANTED AR-8735BV-48.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714501 3.5X50MM BEVELED FT SCREW BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. 3.5X50MM BEVELED FT SCREW UNK 00888867360952

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown