BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_INSTRUMENTSTIRE_PRODUCT

    MDR report key: 8366442 · Received February 25, 2019

    Report

    Report Number
    0001811755-2019-00658
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    November 12, 2018
    Report Date
    April 3, 2019
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ORTHOPAEDIC KNEE REPLACEMENT PROCEDURE. THE BLADE BROKE AT THE MOUNT AS THE SURGEON TRIED TO SAW THE BONE. THERE WAS NO CONTACT BETWEEN THIS BLADE AND METAL INSTRUMENTS. THE BONES CUT DURING THIS PROCEDURE ARE THE TIBIA AND FEMUR. NO FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORTHOPAEDIC KNEE REPLACEMENT PROCEDURE. THE BLADE BROKE AT THE MOUNT AS THE SURGEON TRIED TO SAW THE BONE. THERE WAS NO CONTACT BETWEEN THIS BLADE AND METAL INSTRUMENTS. THE BONES CUT DURING THIS PROCEDURE ARE THE TIBIA AND FEMUR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159703 UNKNOWN_INSTRUMENTSTIRE_PRODUCT BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL GFA STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1