BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER INSTRUMENTS

    MDR report key: 386306 · Received March 25, 2002

    Report

    Report Number
    386306
    Event Type
    Malfunction
    Date Received
    March 25, 2002
    Date of Event
    March 14, 2002
    Report Date
    March 25, 2002
    Manufacturer
    STRYKER INSTRUMENTS, INC
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE, METALLIC FRAGMENTS FROM SAW BLADE WERE FOUND IN PT'S KNEE, FRAGMENTS WERE WASHED OUT WITH PULSE LAVAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER INSTRUMENTS ORTHOPEDIC SAW BLADE HWE STRYKER INSTRUMENTS, INC * 02022097AQ

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other