BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP SHOULDER

    MDR report key: 1931114 · Received November 11, 2010

    Report

    Report Number
    1644408-2010-00596
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - IT APPEARED AS THOUGH THE NIPPLE ON THE END OF THE DISTRACTER WAS TOO LONG. IT WOULD NOT ENGAGE THE THREADS WITHIN THE HUMERAL SOCKET SHELL TO POP THE MORSE TAPER. THERE WAS A TWENTY MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER HEAD DISTRACTOR SHOULDER INSTRUMENT LXH ENCORE MEDICAL, L.P. 36116L01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other