BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER SHAVERS

    MDR report key: 12868780 · Received November 24, 2021

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    Report

    Report Number
    12868780
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    September 28, 2021
    Report Date
    November 19, 2021
    Manufacturer
    PROVISION
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPROCESSED DISPOSABLE ITEM CAUSING METAL SHAVINGS INTRAOPERATIVELY. FORMULA AGRESSIVE PLUS CUTTER 4MM REFERENCE 375-544-000 LOT #12926915. SHOULDER FULL THICKNESS SUPRASPINATUS TEAR- THE DEVIATION OCCURRED IN THE QUALITY CONTROL CHECKING PROCESS OF THE MANUFACTURER. THE ERROR WAS IDENTIFIED ONLY UPON USE AT OUR FACILITY. SURGEON CALLED MANAGER INTO OR DURING PROCEDURE TO SHOW ME THE METAL SHAVINGS THAT WERE IN THE PATIENT FROM THE SHAVER. HE ALSO STATED THAT THE SHAVER DOES NOT ALWAYS ROTATE LIKE IT SHOULD, HE DEMONSTRATED THAT WHEN ACTIVATED THE SHAVER DID NOT ROTATE, BUT DELAYED, THEN WOULD ROTATE. SURGEON DOES NOT WANT TO USE ANY MORE REPROCESSED STRYKER SHAVERS. WILL WORK WITH SUPPLY CHAIN TO GET THESE REPLACED WITH NEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769354 STRYKER SHAVERS ARTHROSCOPE HRX PROVISION 375-544-000 12926915

    Patients

    Seq Age Sex Outcome Treatment
    1 17155 DA Female