BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE

    MDR report key: 1851105 · Received September 24, 2010

    Report

    Report Number
    1851105
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 24, 2010
    Manufacturer
    STRYKER
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    DURING DISASSEMBLY, PIN COLLET USED WITH DRILL WAS NOTED TO BE LEAKING AN OILY SUBSTANCE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================POTENTIAL FOR CONTAMINATION OF OR STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE ARTHROSCOPE, PIN COLLET HRX STRYKER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR NO OTHER THERAPIES