BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2990227 · Received March 5, 2013

    Report

    Report Number
    0001811755-2013-00443
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE MOTOR ASSEMBLY AND THE MOTOR SOCKETS WERE FOUND TO BE CORRODED, WHICH MAY ALLOW THE ACTIVATION OF THE HALL SENSORS, AND IS A PROBABLE CAUSE OF THE REPORTED ACTIVATION WITHOUT USER INPUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY, THE SAW WAS RUNNING WITHOUT USER ACTIVATION AND RUNNING WHEN IN SAFE MODE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93659 MICRO SAGITTAL SAW DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1