BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSION CONTROL STEM INSERTER

    MDR report key: 3945414 · Received July 21, 2014

    Report

    Report Number
    0002249697-2014-02802
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DEVICE NOT RETURNED FOR EVALUATION A REVIEW OF THE DEVICE HISTORY AND COMPLAINT HISTORY RECORDS COULD NOT BE PERFORMED BECAUSE THE DEVICE ASSOCIATED WITH THIS EVENT WAS NOT RETURNED NOR WAS A VALID LOT CODE PROVIDED. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING THE INSERTION OF A PLASMA BOWED 167MM STEM THE VERSION CONTROL HANDLE WOULD NOT DISENGAGE THE STEM. SUBSEQUENTLY THE INTERNAL SHAFT OF THE THREADED INSERTER BROKE. THE THREADED PORTION WAS CONNECTED TO THE STEM WHILE THE HANDLE WAS REMOVED. SURGEON USED VICE GRIPS TO REMOVE THE THREADED SHAFT.

    Description of Event or Problem · 1

    DURING THE INSERTION OF A PLASMA BOWED 167MM STEM THE VERSION CONTROL HANDLE WOULD NOT DISENGAGE THE STEM. SUBSEQUENTLY THE INTERNAL SHAFT OF THE THREADED INSERTER BROKE. THE THREADED PORTION WAS CONNECTED TO THE STEM WHILE THE HANDLE WAS REMOVED. SURGEON USED VICE GRIPS TO REMOVE THE THREADED SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425570 VERSION CONTROL STEM INSERTER INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other