BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SGL TRIG PIN COLLET 2.0 - 3.2MM

    MDR report key: 2082058 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01407
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 RETAIN A PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT RETAIN A PIN DURING ROUTINE MAINTENANCE. 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 SGL TRIG PIN COLLET 2.0 - 3.2MM KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK