BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABO SAG SAW

    MDR report key: 1776029 · Received July 16, 2010

    Report

    Report Number
    1811755-2010-00794
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    June 24, 2010
    Report Date
    June 24, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE HAS BEEN RECEIVED AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE CONTINUED TO RUN ON ITS OWN DURING AN ORTHOPAEDIC PROCEDURE. THE PROCEDURE WAS COMPLETED AND THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES OR DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABO SAG SAW INSTRUMENT, SURGICAL, ORTHOPAEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK