BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOLOCK EX-PIN 3X110

    MDR report key: 3760750 · Received April 21, 2014

    Report

    Report Number
    0001811755-2014-01402
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K022365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED BECAUSE THE DEVICE WILL NOT BE RETURNED FOR ROOT CAUSE ANALYSIS. DEVICE NOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ORTHOLOCK EX-PIN 3X110 BROKE WHEN BEING REMOVED DURING A TOTAL KNEE REPLACEMENT PROCEDURE. THE SURGEON DECIDED TO LEAVE THE BROKEN TIP IN THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239963 ORTHOLOCK EX-PIN 3X110 NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO F02911

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR