BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS POWER SAGITTAL SAW

    MDR report key: 476280 · Received August 1, 2003

    Report

    Report Number
    1643264-2003-00051
    Event Type
    Malfunction
    Date Received
    August 1, 2003
    Report Date
    July 31, 2003
    Manufacturer
    SMITH & NEPHEW, INC. - ENDOSCOPY DIV
    Product Code
    NBH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO SURGERY THE SAW WAS TESTED IN THE OFFICE USING A SAW BONE AND A GLASS OF WATER INTO WHICH THE SAW WAS IMMERESED. NO OIL LEAK WAS NOTED ON THE SAW BONE HOWEVER, ON THE SAGITTAL SAW OIL COULD BE SEEN. WHEN IT WAS PLACED IN THE WATER AND USED, THE WATER BECAME CLOUDY AND SMELLED OF OIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS POWER SAGITTAL SAW SAW NBH SMITH & NEPHEW, INC. - ENDOSCOPY DIV 7205791 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other