BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJ PIN COLLET 2.0-3.2MM

    MDR report key: 3760765 · Received April 21, 2014

    Report

    Report Number
    0001811755-2014-01397
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY, DEBRIS WAS DISCOVERED NEAR THE COLLET WEDGE AND SMALL AMOUNTS OF CORROSION WERE FOUND INTERNALLY. THE PRESENCE OF CORROSION AND DEBRIS CAN CAUSE OR CONTRIBUTE TO METAL SHAVINGS COMING FROM THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNKNOWN PIECES OF BLACK MATERIAL WERE OBSERVED TO COME FROM THE ADJ PIN COLLET 2.0-3.2MM DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT, AND NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239966 ADJ PIN COLLET 2.0-3.2MM INSTRUMENT, SURGICAL, ORTHOPED HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1