BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAS FIX PIN FLUTED 3.2 DIA X 150

    MDR report key: 1722222 · Received June 3, 2010

    Report

    Report Number
    9617840-2010-00003
    Event Type
    Malfunction
    Date Received
    June 3, 2010
    Date of Event
    May 3, 2010
    Report Date
    June 2, 2010
    Manufacturer
    ZIMMER CAS
    Product Code
    HAW
    PMA / PMN Number
    K060336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT'S MANUFACTURING HISTORY DID NOT INDICATE ANY DEVIATIONS OR OTHER POTENTIAL ANOMALIES.

    Description of Event or Problem · 1

    ONE OF THE TEMPORARY FIXATION PINS USED FOR THE TRACKING REFERENCES ON THE FEMUR AND TWO ON THE TIBIA BROKE AT THEIR TIPS DURING A NAVIGATED KNEE REPLACEMENT SURGERY IN FRANCE. THE SURGEON ELECTED TO LEAVE THE BROKEN TIPS OF EACH OF THE RESPECTIVE PINS EMBEDDED IN THE PATIENT'S FEMUR AND TIBIA. THE SURGERY WAS COMPLETED WITHOUT ANY REPORTED FURTHER EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAS FIX PIN FLUTED 3.2 DIA X 150 HAW (STEREOTAXIC INSTRUMENT) HAW ZIMMER CAS 116.015 KD050340

    Patients

    Seq Age Sex Outcome Treatment
    1