BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER INSTRUMENTS

    MDR report key: 353888 · Received September 27, 2001

    Report

    Report Number
    MW1022958
    Event Type
    Malfunction
    Date Received
    September 27, 2001
    Date of Event
    September 21, 2001
    Report Date
    September 27, 2001
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PLASTIC TIP OF SUCTION IRRIGATOR FOUND IN OPERATIVE SITE POST 2 IRRIGATIONS OF OPEN WOUND BUT PRIOR TO WOUND CLOSURE. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43857 STRYKER INSTRUMENTS BONE CLEANING TIP FOR FEMORAL CANAL TIP, IRRIGATION/SUCTION JOL STRYKER INSTRUMENTS 210-10 01080812.8

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR