BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSOURCE DRILL BIT

    MDR report key: 16994621 · Received May 23, 2023

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    Report

    Report Number
    MW5117794
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 10, 2023
    Report Date
    May 21, 2023
    Manufacturer
    GSOURCE, LLC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DRILL BIT TIP BROKE OFF DURING AN ORIF OF PATELLA. REPORTED TO MANUFACTURER. FROM OP NOTE: I WAS DRILLING ONE OF THE BONE TUNNELS IN THE PATELLA A 2 MM DRILL BIT BROKE AND THE BROKEN PIECE WAS DEEP INSIDE THE PATELLA AND IN ORDER TO REMOVE THAT WOULD HAVE REQUIRED BREAKING THE PATELLA APART WHICH OBVIOUSLY WOULD HAVE BEEN A BAD IDEA. IT DID NOT CAUSE ANY PROBLEMS WITH COMPLETING THE CASE AS I WAS ABLE TO REDIRECT THE BONE TUNNEL FOR THE SUTURE PASSAGE WITHOUT COMPLICATION. I ALSO DO NOT EXPECT THIS TO CAUSE ANY SHORT-TERM OR LONG-TERM COMPLICATIONS WITH HIS PATELLA OR HIS RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650304 GSOURCE DRILL BIT BIT, DRILL HTW GSOURCE, LLC. 2.0MM 125/21.5MM GS 86.8221

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other