BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 SAGITTAL SAW

    MDR report key: 2042842 · Received March 30, 2011

    Report

    Report Number
    1811755-2011-01012
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR AND AN EVAL IS ANTICIPATED. THIS REPORT WILL BE UPDATED WHEN THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRIGGER HOUSING ON THE DEVICE HAD AN UNK SUBSTANCE ON IT. THIS WAS DISCOVERED WHILE THE DEVICE WAS AT THE MFR FOR REPAIR. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 6 SAGITTAL SAW KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK