BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER ARTHROSCOPIC SHAVER

    MDR report key: 2113463 · Received May 26, 2011

    Report

    Report Number
    MW5020839
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 23, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE OF OUR ORTHOPEDIC SURGEONS WAS PERFORMING AN ARTHROSCOPIC LEFT SHOULDER PROCEDURE ON HIS PT WITH A STRYKER ARTHROSCOPIC SHAVER AND HE NOTICED SMALL METAL SHAVINGS FALLING OFF TIP OF SHAVER. SURGICAL SITE WAS RINSED WITH COPIOUS AMOUNTS OF SOLUTION. WE HAD SAME PROBLEM EARLIER, REPORT AND DEVICE WAS SENT TO ASCENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ARTHROSCOPIC SHAVER ARTHROSCOPIC SHAVER/BURRS HRX STRYKER MEDICAL 375-940-000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR