BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8013616

    MDR report key: 8013616 · Received October 29, 2018

    Report

    Report Number
    8013616
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 9, 2018
    Report Date
    October 23, 2018
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON DRILLING FOR THE TIBIAL TRACKER PIN, THE DRILL BIT BROKE OFF INSIDE OF THE METAPHYSEAL BONE OF THE TIBIA, BURIED INSIDE THE BONE. SECOND DRILL HOLE WAS MADE AND THEN THE TRACKER PIN WAS MEASURED AND PLACED.

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA