BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2771438 · Received September 28, 2012

    Report

    Report Number
    1811755-2012-03699
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 13, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION WAS DISCOVERED IN THE INTERNAL COMPONENTS OF THE DEVICE, INCLUDING THE MOTOR, WHICH IS A PROBABLE CAUSE OF THE DEVICE SPEEDING UP AND SLOWING DOWN WITHOUT USER ACTIVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BUNIONECTOMY AT THE USER FACILITY, THE SAW WOULD SPEED UP AND SLOW DOWN WITHOUT THE USER CHANGING THE SPEED. BACK-UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. NO DELAY, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION WERE REPORTED.

    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