BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAS FIXATION PIN FLUTED 3.2 DIA X 150

    MDR report key: 1471406 · Received June 16, 2009

    Report

    Report Number
    9617840-2009-00002
    Event Type
    Malfunction
    Date Received
    June 16, 2009
    Date of Event
    April 21, 2007
    Report Date
    June 16, 2009
    Manufacturer
    ORTHOSOFT, INC.(NOW ZIMMER CAS)
    Product Code
    HAW
    PMA / PMN Number
    K060336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED LATE, AS THIS ISSUE WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINT FILES. ANALYSIS OF THE REPORTED EVENT SUPPORTS THAT THE BREAKAGE WAS LIKELY DUE TO INTERFERENCE WITH THE TIBIAL BASEPLATE OR BROACH AS WAS REPORTED. CORRECTIVE ACTION WAS SUBSEQUENTLY TAKEN AT THE TIME TO FURTHER HIGHLIGHT USER INSTRUCTION WARNINGS WITH RESPECT TO POTENTIAL PLACEMENT EFFECTS. ADDITIONAL LOT #: 060470-01.

    Description of Event or Problem · 1

    TOWARDS THE END OF A KNEE REPLACEMENT SURGERY, THE TIP OF ONE OF THE TWO TEMPORARY FIXATION PINS USED FOR THE TRACKING REFERENCE ON THE TIBIA WAS BROKEN WHEN THE PIN WAS REMOVED AND WAS LODGED IN THE TIBIA. THE PIN HAD BEEN REPORTEDLY PLACE THROUGH AN AREA OF THE PROXIMAL TIBIA, WHERE THE KEEL OF THE TIBIAL BASEPLATE IS LOCATED, SUCH THAT WHEN THE SURGEON WAS IMPACTING EITHER THE BROACH OR THE TIBIAL BASEPLATE, THE PIN WAS CROSS-IMPACTED. THE PIN FRAGMENTS WERE REMOVED BY THE SURGEON, AND THE SURGERY WAS COMPLETED WITHOUT ANY FURTHER EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAS FIXATION PIN FLUTED 3.2 DIA X 150 HAW (STEREOTAXIC INSTRUMENT) HAW ORTHOSOFT, INC.(NOW ZIMMER CAS) 116.015 060468-02

    Patients

    Seq Age Sex Outcome Treatment
    1