BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURON SHOULDER INSTRUMENT

    MDR report key: 2152427 · Received June 22, 2011

    Report

    Report Number
    1644408-2011-00354
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT END OF LIFE - THE SURGEON WAS DRILLING THE PEGS FOR THE TURON GLENOID. AS HE REACHED TO POSTERIOR HOLE, THE HUMERUS WAS IMPENDING AND THE DRILL BIT BROKE WHEN IT PRESSED AGAINST THE HUMERUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURON SHOULDER INSTRUMENT GLENOID STOP DRILL HSD ENCORE MEDICAL, L.P. 51653L01

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR