BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK CONNECT DRILL

    MDR report key: 686799 · Received March 8, 2006

    Report

    Report Number
    1825034-2006-00021
    Event Type
    Malfunction
    Date Received
    March 8, 2006
    Date of Event
    January 23, 2006
    Report Date
    February 9, 2006
    Manufacturer
    BIOMET, INC.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING TOTAL HIP ARTHROPLASTY ON JANUARY 23, 2006, TIP OF DRILL BIT BROKE DURING PREPARATION OF THE ACETABULAR SCREW HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK CONNECT DRILL INSTRUMENT, DRILL BIT HTW BIOMET, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention