BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT

    MDR report key: 10167112 · Received June 18, 2020

    Report

    Report Number
    10167112
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 29, 2020
    Report Date
    June 9, 2020
    Manufacturer
    TRIMED, INCORPORATED
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGICAL DRILL BIT SNAPPED DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632415 DRILL BIT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH TRIMED, INCORPORATED 1.8/090

    Patients

    Seq Age Sex Outcome Treatment
    1 18980 DA