BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM 1.5 MM QUICK CHUCK DRILL BIT

    MDR report key: 17860496 · Received October 3, 2023

    Report

    Report Number
    17860496
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    July 10, 2023
    Report Date
    July 28, 2023
    Manufacturer
    AVALIGN TECHNOLOGIES, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A RIGHT TOTAL KNEE ARTHROPLASTY, APPROXIMATELY 1 CM OF THE TIP OF THE DRILL BIT (MILLENNIUM 85-1511023 1.5MM) WAS RETAINED IN THE DISTAL FEMUR. OF NOTE, MILLENNIUM WAS BOUGHT OUT BY AVALIGN TECHNOLOGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590017 MILLENNIUM 1.5 MM QUICK CHUCK DRILL BIT BIT, DRILL HTW AVALIGN TECHNOLOGIES, INC. 85-1511023

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown