BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMB SAG SAW

    MDR report key: 3994152 · Received August 8, 2014

    Report

    Report Number
    0001811755-2014-02815
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS NOT DUPLICATED. DURING FUNCTIONAL INSPECTION THE SERVICE TECHNICIAN NOTED NO FAILURES OR MALFUNCTIONS. AFTER THE FUNCTIONAL INSPECTION THE HANDPIECE WAS DISASSEMBLED AND VISUALLY INSPECTED. DURING THIS VISUAL INSPECTION THE SERVICE TECHNICIAN OBSERVED NO COMPONENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED FAILURE. OTHER COMPONENTS WERE REPLACED DUE TO WEAR AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THE REMB SAGITTAL SAW WAS SLOW TO BRAKE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466716 REMB SAG SAW DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1