BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJ WIRE COLLET 0.7-1.8MM

    MDR report key: 1902859 · Received November 12, 2010

    Report

    Report Number
    1811755-2010-01657
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THIS CONDITION COULD CAUSE THE DEVICE TO STICK, AND NOT ALLOW THE COLLET TO RELEASE THE WIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLLET WOULD NOT RELEASE THE WIRE DURING A PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY AND NO ALLEGATION OF ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADJ WIRE COLLET 0.7-1.8MM INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK