BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT SQC 2.0MM 100/21.5MM

    MDR report key: 20032640 · Received August 21, 2024

    Report

    Report Number
    MW5158653
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    August 13, 2024
    Report Date
    August 19, 2024
    Manufacturer
    GSOURCE LLC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DRILL BIT BROKE DURING ORTHOPEDIC SURGERY. THE DRILL BIT PIECE WAS ABLE TO BE RETRIEVED. THIS IS THE THIRD EVENT REPORTED FOR OUR FACILITY SINCE 6/25/2024 INVOLVING THIS SAME DRILL BIT BREAKING DURING ORTHOPEDIC SURGERY. APIARY MEDICAL INC. REFERENCE REPORTS MW5158654, MW5158655.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381103 DRILL BIT SQC 2.0MM 100/21.5MM BIT, DRILL HTW GSOURCE LLC. GS 86.8220

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male