BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2722100 · Received August 24, 2012

    Report

    Report Number
    1811755-2012-03226
    Event Type
    Malfunction
    Date Received
    August 24, 2012
    Date of Event
    July 25, 2012
    Report Date
    July 26, 2012
    Manufacturer
    STRYKER INSTRUMENTS, INSTRUMENTS DIV.
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION WAS DISCOVERED THROUGHOUT INTERNAL COMPONENTS OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DRILL HEATED UP. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, WITH NO REPORT OF A DELAY. THERE WAS NO PT OR USER INJURY REPORTED, AND NO OTHER ADVERSE CONSEQUENCES ALLEGED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK