BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESECTOR SHAVEBLADES

    MDR report key: 3062720 · Received February 14, 2013

    Report

    Report Number
    3062720
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 14, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS USING STRYKER SHAVER BLADE RESECTOR SHAVER TIPS FOR ARTHROSCOPY. BOTH A REPROCESSED AND A NEW TIP LEFT METAL SHAVINGS IN THE SHOULDER TISSUE. PHOTOS WERE TAKEN AND ARE STORED IN THE MEMORY OF TOWER 1 ORTHO VIDEO SYSTEM. THE SHAVERS HAVE BEEN SEQUESTERED. REPROCESSED 4.0 AND 5.0 SHAVERS HAVE BEEN REMOVED FROM STOCK ALONG WITH NEW STRYKER SHAVERS OF THE SAME LOT NUMBER. THE STRYKER AND STERIMED REPS HAVE BEEN NOTIFIED OF THE INCIDENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SHOULDER ARTHROSCOPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66532 RESECTOR SHAVEBLADES ARTHROSCOPE HRX STERILMED, INC. 0375-552-000 *
    66533 RESECTOR SHAVEBLADES ARTHROSCOPE HRX STRYKER ENDOSCOPY 0375-554-000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR