BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KM166-00-01 TWIST DRILL STANDARD ROUND SHANK LENGTH 5 IN DIAMETER 5/64 IN

    MDR report key: 19549129 · Received June 17, 2024

    Report

    Report Number
    2024102-2024-00008
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    June 3, 2024
    Report Date
    June 17, 2024
    Manufacturer
    BRASSELER U.S.A. MEDICAL, LLC
    Product Code
    HTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BRASSELER IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION. THE ROOT CAUSE CANNOT BE CONFIRMED DUE TO THE INABILITY OF BRASSELER TO PERFORM AN INVESTIGATION OF THE BROKEN DRILL BIT WHICH WAS NOT RETURNED BY THE CUSTOMER.

    Description of Event or Problem · 0

    THE DOCTOR WAS DRILLING INTO THE PATELLA AND THE DRILL BIT KM166-00-01 BROKE OFF IN THE PATIENT'S BONE. THE DOCTOR TOOK AN X-RAY OF OF THE ITEM THAT IS STILL IN THE PATIENT'S BONE. THE DOCTOR DOES NOT PLAN TO REMOVE THE DRILL BIT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614128 KM166-00-01 TWIST DRILL STANDARD ROUND SHANK LENGTH 5 IN DIAMETER 5/64 IN TWIST DRILL HTW BRASSELER U.S.A. MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Other