BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION THIN (9.0 X 0.38 X 25.0MM)

    MDR report key: 11961060 · Received June 8, 2021

    Report

    Report Number
    0001811755-2021-00771
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    March 26, 2021
    Report Date
    July 8, 2021
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    GFA
    UDI-DI
    04546540046499
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MEDWATCH REPORT MW 5100694, THAT THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. AWAITING CONFIRMATION IF DEVICE IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH REPORT MW 5100694, THAT THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853913 PRECISION THIN (9.0 X 0.38 X 25.0MM) BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL GFA STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2296003111 20219037 04546540046499

    Patients

    Seq Age Sex Outcome Treatment
    1