BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOLOCK EX-PIN 3X110

    MDR report key: 2061199 · Received April 5, 2011

    Report

    Report Number
    3007582679-2011-00013
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    STRYKER NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K022579
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIN FRAGMENT HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. THERE WERE NO NONCONFORMANCES OR REWORK INSTRUCTIONS FOR LOTS MANUFACTURED WITHIN 2 WEEKS OF THE PRODUCT MANUFACTURE DATE RELATED TO THE REPORTED FAILURE. THERE WERE NO DESIGN OR PROCESS CHANGES WITHIN 6 MONTHS OF THE PRODUCT MANUFACTURE DATE RELATED TO THE REPORTED EVENT. WHEN THE DEVICE FRAGMENT IS RECEIVED, A QUALITY INVESTIGATION WILL BE PERFORMED AND A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NAVIGATION PIN SHEERED OFF DURING A TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 5MM OF THE TIP REMAINED IN THE TIBIA. THE PIN WAS BEING ANCHORED FOR THE TIBIA WHEN THE PIN BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AS PLANNED, BUT THE PIN COULD NOT BE REMOVED FROM THE TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOLOCK EX-PIN 3X110 HAW STRYKER NAVIGATION W32963

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other