BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT

    MDR report key: 18007 · Received November 29, 1994

    Report

    Report Number
    MW1004164
    Event Type
    Malfunction
    Date Received
    November 29, 1994
    Date of Event
    November 10, 1994
    Report Date
    November 21, 1994
    Manufacturer
    MEDICAL STERILIZATION, INC.
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ORIF, APPROX 3/4" OF DRILL BIT BROKE OFF. DECISION MADE TO LEAVE IT IN PT. NO ADVERSE PT EFFECT. DRILL BIT WAS PART OF INSTRUMENT TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL BIT DRILL BIT HTT MEDICAL STERILIZATION, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR ZIMMER HALLS REAMER DRILL MODEL 5044-01