BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 103078 · Received July 3, 1997

    Report

    Report Number
    MW1011634
    Event Type
    Malfunction
    Date Received
    July 3, 1997
    Date of Event
    May 27, 1997
    Report Date
    June 18, 1997
    Manufacturer
    SYNTHES
    Product Code
    HXS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PIECE OF WIRE TWISTER "METALLIC INSERT" ON DEVICE BROKE OFF FROM INSTRUMENT. NOTICED ON X-RAY IN RECOVERY POSTOP. # ON INSTRUMENT 391.80. AS OF 6/19/97 - NO COMPLICATIONS. PLAN TO EXTRACT FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * "WIRE TWISTER" HXS SYNTHES 391.80 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other