BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.3MM TAPERED ROUTER

    MDR report key: 16929749 · Received May 15, 2023

    Report

    Report Number
    16929749
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    February 17, 2023
    Report Date
    May 1, 2023
    Manufacturer
    STRYKER CORPORATION
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STRYKER DRILL WAS BEING USED TO CREATE A "BURR HOLE" WITH HANDPIECE AND TAPERED ROUTER DRILL BIT WHEN THE DRILL BIT "SNAPPED OFF" AND REMAINED WITHIN THE DRILL HANDPIECE. STRYKER DRILL HANDPIECE AND TAPERED ROUTER DRILL BIT WERE REPLACED AND SURGICAL PROCEDURE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184841 2.3MM TAPERED ROUTER DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE STRYKER CORPORATION 5407FA2023 22347037

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA Male