BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSOURCE, LLC

    MDR report key: 21097821 · Received January 7, 2025

    Report

    Report Number
    2249529-2025-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 9, 2024
    Report Date
    January 7, 2025
    Manufacturer
    GSOURCE, LLC
    Product Code
    HTW
    UDI-DI
    00840314246752
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF 01/07/2025, NO BROKEN PART HAS BEEN RECEIVED BY GSOURCE FROM HOSPITAL. LOT# OF AFFECTED 02 PIECES WAS 5232442 AS PER EMAIL CHAIN FROM HOSPITAL. NO IMAGE OF THE BROKEN PART WAS SHARED WITH GSOURCE. THE EMAIL BRIEFLY MENTIONED BOTH INCIDENTS OF BREAKING DRILL BITS AND REMAINING IN PATIENT'S BODY, HOWEVER, IT DID NOT PROVIDE ANY SPECIFIC DETAILS ABOUT THE TYPE OF SURGERY PERFORMED. INSPECTION DATA SHEET OF GS 86.8427 FOR LN: 5232442 WAS REVIEWED AND FOUND TO BE CONFORMING. THERE WERE (B)(4) PCS IN BATCH WITH LN: 5232442. SEE DHR TRANSACTIONS SNIP WHICH INDICATES THAT (B)(4) PCS AT MOST WERE SHIPPED TO (B)(6) SURGICAL CENTER WITH LN: 5232445, (B)(4) PCS WERE IN STOCK AND ARE CURRENTLY QUARANTINED, THE REST WERE SOLD TO CUSTOMER(S) WITH NO REGISTERED COMPLAINTS. IN THE LAST 10 YEARS, NO COMPLAINT OF BREAKING GS 86.8427 WAS LOGGED ON COMPLAINT LOG. THERE WAS NO SIGNIFICANT DEVIATION IN SELLING QUANTITY OF DRILLS FROM 2023 TO 2024. MANUFACTURING PAPERWORK REVIEWED (CERTIFICATE OF MATERIAL, HEAT TREAT, ETC.) AND FOUND TO BE CONFORMING TO SPECIFICATIONS. RAW MATERIAL WAS PURCHASED FROM EURE INOX FOR LN: 5232442, HOWEVER ALL OTHER MATERIAL CERTIFICATES WITHIN DHR INDICATE KOLB. CHANGING RAW MATERIAL SOURCE DOES NOT HINT AS A ROOT CAUSE BECAUSE THE PREVIOUS BREAKAGE COMPLAINTS HAD KOLB AS RAW MATERIAL PROVIDER. THE WEIGHT OF DRILL BIT WITH LN: 5232442 WEIGHS 4.5 G WHEREAS INSPECTION SAMPLE WEIGHS 5.0 G HENCE NO SIGNIFICANT DEVIATION. THE HARDNESS IS ALSO IN RANGE HENCE COULD NOT VERIFY CUSTOMER'S CLAIM ABOUT "DR THOUGHT THE DRILL BIT LOOKED A LITTLE DIFFERENT AND FELT DIFFERENT." GSOURCE HAS QUARANTINED (B)(4) PCS IN STOCK OF GS 86.8427 WHICH INCLUDES LN[?] 5232442(08), 5232450(70), 5232437(16), 5232431(5), 5232441(20), 5232440(72). IN-HOUSE TESTING CONDUCTED. THE LITERATURE IDENTIFIES DRILL BITS AS SURGICAL EQUIPMENT THAT COMMONLY BREAKS DURING USE. IF A BROKEN PART IS RECEIVED, THEN MORE DETAILS WILL BE ADDED TO THE COMPLAINT FILES AND INCLUDED TO FOLLOW UP MEDWATCH FORM.

    Description of Event or Problem · 0

    TIP OF DRILL BIT BROKE DURING SURGERY AND LEFT IN PATIENT BODY SINCE REMOVING WOULD CAUSE MORE HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870372 GSOURCE, LLC TWIST DRILL 5" STR SHANK DOUBLE FLUTED Ø 2.7MM 30MM ROUND END HTW GSOURCE, LLC 5232442 00840314246752

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other