BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMB SAG SAW

    MDR report key: 2896507 · Received November 20, 2012

    Report

    Report Number
    1811755-2012-04112
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 23, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE, THE MOTOR AND ROTOR WERE FOUND TO BE CORRODED AND THE PRINTED CIRCUIT BOARD (FLEX ASSEMBLY) WAS FOUND TO BE DAMAGED. THE FRICTION CAUSED BY THE CORROSION IS A PROBABLE CAUSE OF THE REPORTED OVERHEATING, AND THE CORROSION IN THE MOTOR AS WELL AS THE DAMAGED PRINTED CIRCUIT BOARD ARE PROBABLE CAUSES OF THE MOTOR TRYING TO RUN WITHOUT USER ACTIVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MFR FACILITY, THE SAW WAS OVERHEATING AND THE MOTOR WAS TRYING TO RUN WITHOUT USER ACTIVATION AFTER THE HANDSWITCH WAS RELEASED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MFR FACILITY, THERE WAS NO PT INVOLVEMENT AND NO DELAY TO THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMB SAG SAW HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK