BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN COLLET

    MDR report key: 1902988 · Received November 12, 2010

    Report

    Report Number
    1811755-2010-01691
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THE IMPREGLON COATING ON THE DEVICE WAS WORN OFF AND WEDGED BETWEEN COLLET SLOTS AND THE WEDGE COLLET. THIS CONDITION COULD CAUSE COLLET TO NOT RETAIN THE PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLLET WILL NOT HOLD A PIN. THE CONDITION OF THE DEVICE WAS DISCOVERED DURING ROUTINE TESTING IN HOUSE. THERE WAS NO PT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIN COLLET INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK