BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSOURCE

    MDR report key: 23419729 · Received October 29, 2025

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    2249529-2025-00005
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    August 19, 2025
    Report Date
    October 29, 2025
    Manufacturer
    GSOURCE, LLC.
    Product Code
    HTW
    UDI-DI
    00840314246554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DETAILS THE INVESTIGATION OF BREAKAGES OF DRILL BIT SQC 2.0MM 125/21.5MM. AFTER COMMUNICATING WITH THE HEALTHCARE PROFESSIONAL, THE LOT NUMBER OR COMPLAINT PART WERE NOT AVAILABLE. BASED ON LITERATURE, THE SMALLER DRILL BIT SIZE IS NOT RECOMMENDED FOR USE IN TOTAL HIP ARTHROPLASTY PROCEDURES. BASED ON INTERNAL TESTING IT DOES NOT APPEAR TO BE A PRODUCT DESIGN RELATED ISSUE. HOWEVER, THE DESIGN WAS IMPROVED TO MAKE IT MORE ROBUST.

    Description of Event or Problem · 0

    A DRILL BIT BROKE WHILE PERFORMING A TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686846 GSOURCE DRILL BIT SQC 2.0MM 125/21.5MM HTW GSOURCE, LLC. GS 86.8221 00840314246554

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female