BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMB OSC SAW

    MDR report key: 2754172 · Received September 12, 2012

    Report

    Report Number
    1811755-2012-03476
    Event Type
    Malfunction
    Date Received
    September 12, 2012
    Date of Event
    August 15, 2012
    Report Date
    August 15, 2012
    Manufacturer
    STRYKER INSTRUMENTS, INSTRUMENTS DIV.
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON VISUAL EXAMINATION, IT WAS OBSERVED THAT THE SOCKETS WERE CORRODED. UPON DISASSEMBLY, IT WAS OBSERVED THAT THERE WAS WIDESPREAD CORROSION AND THE BEARINGS WERE WORN. THE PRESENCE OF WIDESPREAD CORROSION IS LIKELY TO CAUSE OR CONTRIBUTE TO THE HAND PIECE OVERHEATING.

    Description of Event or Problem · 1

    THE REMB OSCILLATING SAW WAS RETURNED FOR SERVICE. UPON EVAL AT THE MFR, IT WAS FOUND TO OVERHEAT. THERE WAS NO PT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK