BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE OSC SAW

    MDR report key: 2200936 · Received July 1, 2011

    Report

    Report Number
    1811755-2011-02369
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE CHEMICAL REPORT THE SAMPLE SHOWS A CLOSE SPECTRAL MATCH TO BIOGENIC MATERIALS SUCH AS HUMAN BLOOD; A RESIN LIKE TOLUENESULFONAMIDE / FORMALDEHYDE RESIN AND AN INORGANIC SUCH AS TALC. NO MATCHES FROM THE STRYKER FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY) REFERENCE COMPOUND LIBRARY WERE FOUND. THE BIOGENIC MATERIAL MAY HAVE BEEN INTRODUCED DURING A SURGERY AND THE RESIN AND TALC WHICH ARE COMMONLY FOUND IN LUBRICANTS AND CLEANING AGENTS MAY HAVE BEEN INTRODUCED DURING THE CLEANING PROCESS. IMPROPER CLEANING DURING THE CLEANING PROCESS CAN RESULT IN ACCUMULATION OF FLUID AND FOREIGN SUBSTANCES IN THE DEVICE; THIS MAY LATER PRESENT AS A LEAKING SUBSTANCE. ALTERNATIVELY, THE DEVICE CAN ALSO HOLD FLUID IF IT HAS BEEN OVERSATURATED AND NOT ALLOWED TO COMPLETELY DRAIN AND DRY. THE STRYKER CARE INSTRUCTIONS AND INSTRUCTIONS FOR USE PROVIDES THE PROPER CLEANING INSTRUCTIONS FOR THE DEVICE.

    Description of Event or Problem · 1

    THE CORE OSCILLATING SAW WAS SENT IN FOR SERVICE AND A BLACK SUBSTANCE WAS COMING OUT OF THE DEVICE DURING THE SERVICE. A SAMPLE WAS TAKEN AND SENT FOR ANALYSIS; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK