BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CORE

    MDR report key: 3131580 · Received May 20, 2013

    Report

    Report Number
    3131580
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 20, 2013
    Manufacturer
    STRYKER INSTRUMENTS, INSTRUMENTS DIV
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    BLACK POWDER/PARTICLE CAME OUT OF STRYKER POWER CORE HANDLE BAR DURING LEFT FOOT CHEVRON SURGERY. SURGERY FIELD WAS CONTAMINATED. APPARENTLY, THIS DEVICE HAS A LUBRICANT AND OUR STERILE SUPPLY DEPARTMENT DOES NOT LUBRICATE THIS DEVICE. HOWEVER, THIS IS NOT IMMERSED IN WATER EITHER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SURGERY TO BUNION ON FOOT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223074 POWER CORE INSTRUMENT, SURGICAL HWE STRYKER INSTRUMENTS, INSTRUMENTS DIV * *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR