BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 SAGITTAL SAW

    MDR report key: 2132293 · Received June 11, 2011

    Report

    Report Number
    1811755-2011-02124
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MFR FOR SERVICE AND EVALUATION. DURING THE INVESTIGATION, A RUN-ON CONDITION WAS FOUND. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS THE MOTOR CONTROLLER MOUNTING SCREW BECAME LOOSE AND LODGED ITSELF BETWEEN THE TRIGGER MAGNET AND THE FRONT PLATE.

    Description of Event or Problem · 1

    THE HANDPIECE WAS RETURNED TO THE MFR FOR SERVICE, AND DURING THE INVESTIGATION, THE DEVICE HAD A RUN-ON CONDITION. THERE WAS NO PT INVOLVEMENT DURING THIS EVENT. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 5 SAGITTAL SAW KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK