BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNTHES USA

    MDR report key: 244623 · Received October 12, 1999

    Report

    Report Number
    MW1017310
    Event Type
    Other
    Date Received
    October 12, 1999
    Date of Event
    September 28, 1999
    Report Date
    October 5, 1999
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTT
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING O.R. PROCEDURE FOR REPAIR OF FRACTURED TIBIA THE DRILL BIT BROKE OFF AND WAS LEFT RETAINED IN BONE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES USA SURGICAL DRILL BIT HTT SYNTHES (USA) 310.25 A613219

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other