BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2241582 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03238
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 5, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MFR AND THE EVENT AS REPORTED WAS DUPLICATED. THE BALL BEARING ON THE ROTOR HAS SHATTERED, THERE IS CORROSION AND DEBRIS THROUGH THE INSIDE OF THE HANDPIECE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE WAS OVERHEATING DURING TESTING. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    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