BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN COLLET

    MDR report key: 1841977 · Received August 26, 2010

    Report

    Report Number
    1811755-2010-01015
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND IT WAS DETERMINED THAT THE ROOT CAUSE OF THE PIN STICKING IS DUE TO THE WEAR AND FLAKING OF THE IMPREGLON COATING. THIS COATING IS USED INSIDE OF THE COLLET TO PREVENT THE PIN FROM STICKING. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFO FROM THE INVESTIGATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLLET WOULD NOT HOLD 3.2 MM PINS. THIS WAS FOUND PRIOR TO SURGERY AND ANOTHER DEVICE AND COMPLETED SURGERY. THERE WERE NO ADVERSE CONSEQUENCES OR DELAYS RELATED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK