BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOMET, INC.

    MDR report key: 282412 · Received June 16, 2000

    Report

    Report Number
    282412
    Event Type
    Other
    Date Received
    June 16, 2000
    Date of Event
    April 14, 2000
    Report Date
    May 2, 2000
    Manufacturer
    BIOMET, INC.
    Product Code
    LXH
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT SCHEDULED FOR A RIGHT TOTAL KNEE ARTHROPLASTY DURING THE PROCEDURE, WHILE USING A 3.2MM DRILL BIT IN THE RIGHT KNEE THE DRILL BIT BROKE OFF. SURGEON WAS AWARE OF THIS INCIDENT. BROKEN DRILL BIT WAS LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET, INC. DRILL BIT 3.2MM 1/8" LXH BIOMET, INC. 32.46762.3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other