BEUDAMED
    FDA Adverse Event Other Summary report: N

    4.0MM THREE-FLUTED DRILL BIT

    MDR report key: 61528 · Received January 6, 1997

    Report

    Report Number
    1719045-1996-00013
    Event Type
    Other
    Date Received
    January 6, 1997
    Date of Event
    October 31, 1996
    Report Date
    October 31, 1996
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRILL BIT (TIP) BROKE OFF IN PT DURING SURGERY. A PIECE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM THREE-FLUTED DRILL BIT DRILL BIT HTW SYNTHES USA NA A5DA029

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other