BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 3163406 · Received June 11, 2013

    Report

    Report Number
    0001811755-2013-01336
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 17, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S EVALUATION OF THE RETURNED SAGITTAL SAW WITH ANOTHER BLADE OF THE SAME MODEL DID NOT CONFIRM THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BLADE CAME OUT OF THE MICRO SAGITTAL SAW DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264183 MICRO SAGITTAL SAW DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) SAGITTAL SAW BLADE