BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 6629452 · Received June 9, 2017

    Report

    Report Number
    6629452
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    June 6, 2017
    Report Date
    June 7, 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

    WHILE REPAIRING ACL IN O.R. THE STRYKER BURR LEFT METAL SHAVINGS IN THE TISSUE. THIS WAS NOT A REPROCESSED UNIT. NAME OF PRODUCT IS AS FOLLOWS: STRYKER ARTHROSCOPIC SHAVER BLADE. REF 0375-951-000 EXP. 10/13/21. BURR IS AN AGGRESSIVE 6-FLUTE BARREL BUR 5.5MM X 125MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411168 N/A ARTHROSCOPE HRX STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A 16288CE2

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR