BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAW

    MDR report key: 300951 · Received October 10, 2000

    Report

    Report Number
    MW1020182
    Event Type
    Malfunction
    Date Received
    October 10, 2000
    Date of Event
    September 19, 2000
    Report Date
    October 3, 2000
    Manufacturer
    STRYKER
    Product Code
    DZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE DR OBSERVED A SUSPICIOUS IMAGE ON AN X-RAY. THE PT HAD A TOTAL KNEE PROCEDURE. A 1/4 INCH PIECE OF METAL WAS REMOVE FROM THE KNEE. IT WAS DETERMINED THAT THIS METAL WAS DEFINITELY FROM A STRYKER SCREW BLADE. THE SAME WEEK ON ANOTHER PT HOSP HAD A SIMILAR OCCURRENCE OF THE METAL CLIP SHEARING OFF A STRYKER BLADE AND FALLING INTO THE OPERATING SITE. THE PIECE WAS REMOVED. THE HOSP HAS SWITCHED TO ANOTHER BLADE FOR FUTURE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAW SAW BLADE DZH STRYKER 2108 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other