BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSOURCE

    MDR report key: 25021644 · Received April 28, 2026

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    Report

    Report Number
    2249529-2026-00001
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Report Date
    April 27, 2026
    Manufacturer
    GSOURCE, LLC.
    Product Code
    HTW
    UDI-DI
    00840314246721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DETAILS THE INVESTIGATION OF A BREAKAGE OF TWIST DRILL 5 INCH STRAIGHT SHANK DOUBLE FLUTED DIAMETER 2.0MM 23MM ROUND END. BASED ON THE RECEIVED INFORMATION, THE DRILL BIT SIZE WAS USED IN A PROCEDURE INVOLVING THE FEMUR. THE LIKELY ROOT CAUSE OF THE BREAKAGE IS THE USAGE OF A DRILL BIT DIAMETER (Ø 2.0MM) THAT IS TOO THIN FOR USAGE IN THE FEMUR DUE TO ITS HIGH BONE DENSITY. USING THIS THIN DIAMETER ON THE FEMUR ALSO MAKES THE DRILL MORE SUSCEPTIBLE TO BREAKAGE IF EXCESSIVE FORCE IS APPLIED OR FORCE APPLIED AT AN INCORRECT ANGLE. IN 2025, GSOURCE QUALITY AND ENGINEERING HAVE ALREADY IMPROVED THE DRILL BIT DESIGN TO CORRECT/PREVENT BREAKAGES AND HAVE MADE A GENERAL INSTRUCTIONS FOR USE ASSISTING HEALTHCARE PROFESSIONALS WITH THE SELECTION AND PROPER USAGE OF DRILL BITS FOR MEDICAL PROCEDURES.

    Description of Event or Problem · 0

    A DRILL BIT BROKE OFF INTO THE PATIENT'S FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231283 GSOURCE TWIST DRILL 5" STR SHANK DOUBLE FLUTED Ø 2.0MM 23MM ROUND END HTW GSOURCE, LLC. GS 86.8420 5232541 00840314246721

    Patients

    Seq Age Sex Outcome Treatment
    1