BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEG ALIGNMENT SOUND

    MDR report key: 2935705 · Received January 3, 2013

    Report

    Report Number
    2249697-2013-90006
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS DOING A TOTAL ARTHROPLASTY ON PATIENT'S LEFT SIDE AND THE SUPERIOR PEG SNAPPED OFF THE ALIGNMENT GUIDE WHILE SURGEON WAS DOUBLE CHECKING THE ALIGNMENT. THERE WAS NO DELAY IN SURGERY OR ADVERSE CONSEQUENCES TO PATIENT AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3908 PEG ALIGNMENT SOUND INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA NW107177

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR