BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTICAL BONE SCREW, Ø3.5MM X 32MM

    MDR report key: 23659359 · Received November 26, 2025

    Report

    Report Number
    1220246-2025-05229
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 5, 2025
    Report Date
    March 9, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    KTW
    UDI-DI
    00848665033236
    PMA / PMN Number
    K080590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3, H3, H6 BASED ON THE INFORMATION PROVIDED ¿ WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT ¿ ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO USER-RELATED FACTORS SUCH AS MECHANICAL OVERSTRESS, OFF-AXIS LOADING, OR IMPROPER BONE PREPARATION.

    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: DURING THE PROCEDURE, A 3025-018 ALPHA PLATE, RIGHT, 18-HOLE WAS USED WHEN AN 8110-032 CORTICAL BONE SCREW (3.5 MM X 32 MM) FRACTURED DURING INSERTION. NO OTHER SCREWS WERE IMPLICATED, AND NO DAMAGE OR MALFUNCTION WAS REPORTED WITH THE ALPHA PLATE. TO COMPLETE THE CASE, ADDITIONAL SCREWS WERE USED, INCLUDING TWO AR-8935-26 LOW PROFILE SCREW (3.5 X 26 MM) AND ONE AR-8935 LOW PROFILE SCREW FROM THE TITANIUM ANKLE FRACTURE SET. THE SURGERY WAS DELAYED BY APPROXIMATELY 45 MINUTES, AND IT IS UNCLEAR WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED DURING THIS TIME. THE PATIENT¿S BONE QUALITY WAS ASSESSED AS GOOD, AND BONE PREPARATION FOR IMPLANT INSERTION WAS PERFORMED USING AN AR-8943-30 2.5 MM DRILL BIT FROM THE TITANIUM ANKLE FRACTURE SET. NO FURTHER INTERVENTION WAS CONSIDERED OR PLANNED TO RETRIEVE THE SCREW FRAGMENT.

    Description of Event or Problem · 0

    ON 11/06/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN 8110-032 CORTICAL BONE SCREW, 3.5 MM X 32 MM, SNAPPED OFF DURING INSERTION WITH AN ALPHA PLATE. THE BREAK OCCURRED IN THE HUMERUS, AND THE BROKEN SCREW FRAGMENT WAS LEFT IN THE PATIENT. THIS ISSUE WAS IDENTIFIED DURING A PROXIMAL HUMERUS FRACTURE PROCEDURE PERFORMED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2813210 CORTICAL BONE SCREW, Ø3.5MM X 32MM FIXATN NAIL/BLADE/PLATE COMBO KTW ARTHREX, INC. CORTICAL BONE SCREW, Ø3.5MM X 32MM 240991 00848665033236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown