BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R/R ADJ PIN COLLET

    MDR report key: 1972744 · Received January 21, 2011

    Report

    Report Number
    1811755-2011-00199
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    December 31, 2010
    Report Date
    December 31, 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
    OTHER

    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 NOT RETAIN THE WIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS SENT IN FOR TESTING. WHILE IN TESTING IN HOUSE, IT WAS DETERMINED THAT THE SMALL K-WIRE SLIPS WHEN DRILLING. THERE WAS NO PT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK