BEUDAMED
    FDA Adverse Event Other Summary report: N

    1" HEADED FIXATION PIN

    MDR report key: 1343935 · Received March 13, 2009

    Report

    Report Number
    2249697-2009-00132
    Event Type
    Other
    Date Received
    March 13, 2009
    Date of Event
    February 18, 2009
    Report Date
    February 18, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVALUATION - THE RESULTS OF THE INVESTIGATION INDICATE THAT THE ROOT CAUSE OF THE EVENT WAS TECHNIQUE RELATED, BASED ON THE INTAKE. FURTHER INVESTIGATION COULD NOT BE PERFORMED AS NO DEVICE LOT INFO WAS REPORTED OR CLINICAL INFO PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE SURGEON FOUND THE 1" HEADED FIXATION PIN INTO THE PT'S TIBIAL CANAL ON THE X-RAY OF IMMEDIATE AFTER SURGERY. THE SURGEON PROBABLY PROPPED OFF THE ONE INTO THE PT'S TIBIAL CANAL ACCIDENTALLY. THE SURGEON REMAINED IT AND WILL TAKE A WAIT-AND-SEE APPROACH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1" HEADED FIXATION PIN INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other