BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJ PIN COLLET 2.0-3.2MM

    MDR report key: 1970387 · Received January 18, 2011

    Report

    Report Number
    1811755-2011-00171
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    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 MANUFACTURER FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THE IMPREGLON COATING ON THE DEVICE WAS WORN OFF. THIS CONDITION COULD CAUSE THE DEVICE TO NOT HOLD THE PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLLET WOULD NOT HOLD THE SMALL PIN DURING TESTING IN HOUSE. THERE WAS NO PATIENT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADJ PIN COLLET 2.0-3.2MM INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK