BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURON SHOULDER INSTRUMENT

    MDR report key: 1963329 · Received December 14, 2010

    Report

    Report Number
    1644408-2010-00658
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - THE DRILL BIT SNAPPED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURON SHOULDER INSTRUMENT GLENOID STOP DRILL KWS ENCORE MEDICAL, L.P. NA

    Patients

    Seq Age Sex Outcome Treatment
    1