BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSOURCE

    MDR report key: 23249758 · Received October 8, 2025

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    Report

    Report Number
    2249529-2025-00004
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Report Date
    October 7, 2025
    Manufacturer
    GSOURCE, LLC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DETAILS THE INVESTIGATION OF BREAKAGES OF DRILL BIT SQC 1.5MM 85/18MM (REFERENCE CC# (B)(4). AFTER INTERNAL REVIEW OF RETURNED SAMPLES, IT WAS DETERMINED THAT THE CAUSE OF THE BREAKAGES WAS DUE TO A VARIATION IN CORE THICKNESS DURING THE MANUFACTURING OF LOT 2205. THIS DOES NOT APPEAR TO BE A PRODUCT DESIGN ISSUE AS OVER (B)(4) UNITS WERE SOLD BETWEEN 2022-PRESENT AND THERE WERE NO REPORTED COMPLAINTS. SUBSEQUENT LOTS FROM INVENTORY WERE REVIEWED AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 0

    FOUR DRILL BITS OF THE SAME LOT BROKE DURING SURGERY ON TWO SEPARATE OCCASIONS AND NONE OF THEM REMAINED IN THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2512498 GSOURCE DRILL BIT SQC 1.5MM 85/18MM HTW GSOURCE, LLC. GS 86.8215 2205

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown