BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 6676848 · Received June 29, 2017

    Report

    Report Number
    6676848
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    April 7, 2017
    Report Date
    June 6, 2017
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING A SHOULDER ARTHROSCOPY, DURING THE PROCEDURE SHAVER HEAD BROKE OFF IN SHOULDER DURING USE. SHAVER RETRIEVED BY PHYSICIAN INTACT. ON SHAVER PACKAGING IT STATES REPROCESSED BY STRYKER SOLUTIONS. BLADE AGGRESSIVE PLUS 40. ARTHROSCOPIC CUTTER WAS REPROCESSED BY STRYKER SUSTAINABILITY SOLUTIONS. PHYSICIAN STATED HE HAS HAD THE SAME EVENT OCCUR WITH PREVIOUS REPROCESSED SUPPLIES AND STATED HE DOES NOT WANT TO USE THESE ITEMS IN ANY OF HIS FUTURE SURGICAL PROCEDURES. THE TIP OF THE CUTTER BROKE OFF IN THE PATIENT'S SHOULDER AND WAS RETRIEVED BY PHYSICIAN. THE PATIENT WAS DISCHARGED SAME DAY FROM RECOVERY WITHOUT COMPLICATIONS. REEVALUATE USE OF CERTAIN REPROCESSED SUPPLIES WITH POTENTIAL OF BREAKAGE DURING USE. CHECK WITH STRYKER SUSTAINABILITY SOLUTIONS OF THE PROCESS AND IF IT MAY CAUSE WEAKENING OR ALTERATION OF MATERIAL WITH REPROCESSING THAT COULD CAUSE POTENTIAL BREAKAGE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458248 N/A ARTHROSCOPE HRX STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A 5564387

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR