BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURON SHOULDER INSTRUMENT

    MDR report key: 2052151 · Received March 1, 2011

    Report

    Report Number
    1644408-2011-00117
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    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/END OF LIFE - THE 5.0 GLENOID DRILL ON THE TURON TOTAL SHOULDER SYSTEM BROKE. TORQUED ON DRILL IN GUIDE WHEN THE SURGEON WAS DRILLING. THE HOLE HE WAS OPERATING THROUGH WAS TIGHT, A BAD ANGLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURON SHOULDER INSTRUMENT GLENOID STOP DRILL KWS ENCORE MEDICAL, L.P. 51653L01B

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR