BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTICAL SCREW, 3.5MM X 30MM

    MDR report key: 23209433 · Received October 3, 2025

    Report

    Report Number
    1220246-2025-04386
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 22, 2025
    Report Date
    January 27, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    KTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THAT A 8010-300 CORTICAL SCREW, BATCH 240518, IS FRACTURED. 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 MISUSE DUE TO USE-RELATED FACTORS, RESULTING IN MECHANICAL OVERLOAD OF THE DISTAL LOCKING SCREWS DURING INSERTION.

    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 (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO 3.5MM DISTAL LOCKING SCREWS FROM THE HUMERAL NAIL SYSTEM BROKE DURING A CASE. THESE SCREWS WERE TARGETED USING THE FREEHAND TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE ISSUE WAS DISCOVERED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 09/29/2025: DURING A HUMERAL NAIL PROCEDURE FOR A MIDSHAFT HUMERAL FRACTURE ORIF ON (B)(6) 2025, TWO CORTICAL SCREWS, AN 8010-300 (3.5MM X 30MM) AND AN 8010-275 (3.5MM X 27.5MM), BROKE AT THE END OF THE CASE WHILE INSERTING THE DISTAL SCREWS, WHICH REQUIRED PERFECT CIRCLES. THE SCREW HEADS WERE SUCCESSFULLY REMOVED FROM THE PATIENT, WHILE THE REMAINING PORTIONS WERE LEFT IN PLACE IN THE CORTICAL BONE. THE PROCEDURE WAS COMPLETED WITHOUT THE NEED FOR ADDITIONAL SCREWS OR HARDWARE, AND NO CHANGES WERE MADE TO THE SURGICAL PLAN. THE INCIDENT EXTENDED THE OPERATIVE TIME BY APPROXIMATELY 15 MINUTES BUT DID NOT REQUIRE ADDITIONAL ANESTHESIA. BONE PREPARATION WAS NOT PERFORMED, AND BONE QUALITY WAS ASSESSED AS GOOD. NO ADVERSE EFFECTS WERE REPORTED DURING OR AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204183 CORTICAL SCREW, 3.5MM X 30MM FIXATN NAIL/BLADE/PLATE COMBO KTW ARTHREX, INC. CORTICAL SCREW, 3.5MM X 30MM 240518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown