BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2213831 · Received August 4, 2011

    Report

    Report Number
    1811755-2011-02820
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MFR AND THE EVENT AS REPORTED BY THE CUSTOMER WAS DUPLICATED. THE DEVICE IS STILL PENDING INVESTIGATION. THIS REPORT WILL BE UPDATED WHEN THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE WAS RUNNING WITH THE SAFETY ON. THIS WAS DISCOVERED DURING A PROCEDURE. A BACKUP UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO SAGITTAL SAW ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK