BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI

    MDR report key: 24344243 · Received February 16, 2026

    Report

    Report Number
    1220246-2026-00599
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    January 28, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867303829
    PMA / PMN Number
    K191326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 28-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-18714-12 CORTICAL SCREW (1.4 MM × 12 MM) EXPERIENCED A HEAD FRACTURE DURING INSERTION. THE SCREW WAS BEING PLACED INTO A HOLE OF A 10-HOLE 1.4 MM PLATE AND HAD BEEN ADVANCED NEARLY FLUSH TO THE PLATE WHEN THE HEAD SEPARATED FROM THE SHAFT. THE SURGEON REMOVED ONLY THE SCREW HEAD, LEAVING THE SCREW SHAFT IN SITU BECAUSE IT CROSSED THE FRACTURE SITE. THE EVENT OCCURRED DURING A METACARPAL FRACTURE INTERNAL FIXATION PROCEDURE ON (B)(6) 2026. THE ISSUE DID NOT CAUSE PROCEDURAL DELAY, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 03-FEB-2026: THERE WAS NO REPORTED DAMAGE TO THE AR-18714P-07 STRAIGHT PLATE, 1.4 MM, 10-HOLE ASSOCIATED WITH THIS EVENT. THE ONLY ISSUE IDENTIFIED INVOLVED A SINGLE AR-18714-12 CORTICAL SCREW (1.4 MM × 12 MM), AS SHOWN IN THE ATTACHED PHOTO. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE AFFECTED SCREW REMAINED IMPLANTED. ADDITIONAL SCREWS MEASURING 10 MM, 11 MM, 12 MM, AND 15 MM IN LENGTH WERE ALSO UTILIZED AS PART OF THE CONSTRUCT. NO ADVERSE PATIENT EFFECTS WERE REPORTED IN RELATION TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11880 LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI BONE FIXATION PLATE HRS ARTHREX, INC. LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI UNK 00888867303829

    Patients

    Seq Age Sex Outcome Treatment
    1