BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMB OSC SAW

    MDR report key: 2130038 · Received May 5, 2011

    Report

    Report Number
    1811755-2011-01617
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION REVEALED A BROKEN BALL BEARING AND A CORRODED MOTOR ASSEMBLY. THE CORRODED MOTOR ASSEMBLY WAS IDENTIFIED AS THE PROBABLE CAUSE OF THE FAILURE SINCE AN INTERMITTENT CONNECTION AT THE ANALOG GROUND PIN MAY RESULT FROM THIS CORROSION AND CAUSE THE DEVICE TO RUN ON ITS OWN W/O ACTIVATION. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE REMB OSCILLATING SAW WAS SENT IN FOR REPAIR AND IT RAN ON ITS OWN W/O ACTIVATION DURING TESTING. THERE WAS NO PT INVOLVEMENT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMB OSC SAW HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK