BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIBRATED DRILL BIT

    MDR report key: 12031647 · Received June 21, 2021

    Report

    Report Number
    12031647
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 2, 2021
    Report Date
    June 2, 2021
    Manufacturer
    BIOMET ORTHOPEDICS, LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TIP OF DRILL BIT BROKE OFF IN BONE, IN PATIENT'S ARM, DURING SURGERY. BROKEN DRILL BIT WASN'T SAVED; DRILL BIT TIP REMAINS IN PATIENT'S LEFT OLECRANON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928397 CALIBRATED DRILL BIT BIT, DRILL HTW BIOMET ORTHOPEDICS, LLC 2142-27-070

    Patients

    Seq Age Sex Outcome Treatment
    1 9855 DA