BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PK/5 NAVIGATION PIN 3MMX100MM

    MDR report key: 1171099 · Received September 19, 2008

    Report

    Report Number
    8010177-2008-00066
    Event Type
    Injury
    Date Received
    September 19, 2008
    Date of Event
    August 14, 2006
    Report Date
    August 14, 2006
    Manufacturer
    STRYKER NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K022365
    Removal / Correction Number
    18117556/5/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL. A RECALL WAS INITIATED ON THE INSTRUCTIONS FOR USE FOR THESE PINS. THE INSTRUCTIONS FOR USE WAS REVISED AND NOW CONTAINS NEW WARNINGS REGARDING ASPECTS OF PIN PLACEMENT IN THE FEMUR AND TIBIA.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT AT 10 WEEKS POST OP TKA, A PT PRESENTED WITH PAIN OVER THE PIN SITES ON HIS TIBIA AND MUCH TENDERNESS OVER THE DISTAL PIN SITE. ALTHOUGH X-RAYS DID NOT SHOW A FRACTURE, AN MRI SHOWED A STRESS FRACTURE OF THE MID TIBIA. THE FRACTURE WAS TREATED BY NON-OPERATIVE MEANS SUCH AS PROTECTED WEIGHT BEARING, BRACING AND EXTERNAL BONE STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK/5 NAVIGATION PIN 3MMX100MM STEREOTAXIC INSTRUMENT HAW STRYKER NAVIGATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention