BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER ORTHOPEDICS

    MDR report key: 3890098 · Received June 2, 2014

    Report

    Report Number
    3890098
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE COMPLETION OF A TOTAL KNEE ARTHROPLASTY IT WAS NOTED THAT ONE OF THE NAVIGATION PINS FROM THE TIBIA WAS MISSING THE TIP. THE PHYSICIAN WAS AWARE THE TIP HAS BROKEN OFF, BUT FELT IT WOULD CAUSE MORE DAMAGE TO DIG FOR THE TIP OF THE SCREW BECAUSE IT IS VERY SMALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322528 STRYKER ORTHOPEDICS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM JWH STRYKER ORTHOPAEDICS * F02911

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR