BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN COLLET

    MDR report key: 3013153 · Received March 20, 2013

    Report

    Report Number
    0001811755-2013-00556
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 5, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION, METAL SHAVINGS WERE CONFIRMED AND THE DEVICE HAD SCORE MARKS ON THE DRIVESHAFT WHERE THE THRUST WASHER RIDES. THE METAL REMOVED FROM THE SCORING WAS LIKELY WHAT WAS OBSERVED COMING FROM THE DEVICE. THE DEVICE CAN PRODUCE METAL SHAVINGS DUE TO DRIVESHAFT WEAR WHICH IS THE LIKELY CAUSE OF THE REPORTED EVENT OF BLACK PARTICLES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND EVALUATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK PARTICLES WERE COMING OUT OF THE DEVICE. THE EVENT OCCURRED DURING A PROCEDURE. THE PATIENT WAS NOT AFFECTED AND NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK PARTICLES WERE COMING OUT OF THE DEVICE. THE EVENT OCCURRED DURING A PROCEDURE. THE PATIENT WAS NOT AFFECTED AND NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116527 PIN COLLET ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1