BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOLOCK EX-PIN 3X110

    MDR report key: 4242382 · Received November 11, 2014

    Report

    Report Number
    0001811755-2014-04019
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    August 12, 2014
    Report Date
    October 14, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K022365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT RETURN THE DEVICE TO THE MANUFACTURING FACILITY FOR FAILURE ANALYSIS; THEREFORE, NO DEVICE EVALUATION WAS PERFORMED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL RIGHT KNEE ARTHROPLASTY, THE TIP OF THE ORTHOLOCK EX-PIN 3X110 BROKE OFF DURING INSERTION INTO THE PATIENT'S TIBIA. THE SURGEON ELECTED NOT TO REMOVE THE BROKEN FRAGMENT FROM THE TIBIAL BONE. THIS WAS THE INITIAL USE OF THE PIN. NO ADVERSE CONSEQUENCES AND NO CLINICALLY SIGNIFICANT DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING NAVIGATION. AFTER FOLLOW-UP, NO FURTHER INFORMATION WAS AVAILABLE REGARDING THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL RIGHT KNEE ARTHROPLASTY, THE TIP OF THE ORTHOLOCK EX-PIN 3X110 BROKE OFF DURING INSERTION INTO THE PATIENT'S TIBIA. THE SURGEON ELECTED NOT TO REMOVE THE BROKEN FRAGMENT FROM THE TIBIAL BONE. THIS WAS THE INITIAL USE OF THE PIN. NO ADVERSE CONSEQUENCES AND NO CLINICALLY SIGNIFICANT DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING NAVIGATION. AFTER FOLLOW-UP, NO FURTHER INFORMATION WAS AVAILABLE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726854 ORTHOLOCK EX-PIN 3X110 NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO F03929

    Patients

    Seq Age Sex Outcome Treatment
    1