BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEQUALIS REVERSED HEX SCREWDRIVER BIT

    MDR report key: 11670394 · Received April 15, 2021

    Report

    Report Number
    3009351194-2021-00036
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 17, 2021
    Report Date
    March 17, 2021
    Manufacturer
    TORNIER S.A.S.
    Product Code
    HXX
    UDI-DI
    03700386943775
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS REGARDING MEDICAL DEVICE REPORTING AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY OR MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT A DEVICE HAS MALFUNCTION OR IS RELATED TO A DEATH OR INJURY.

    Description of Event or Problem · 1

    THE TIP OF THE DRIVER BROKE OFF IN THE GLENOSPHERE. TIP COULD NOT BE FOUND & WAS LEFT IN PATIENT. ABOUT 5 MINUTES WAS ADDED TO CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567892 AEQUALIS REVERSED HEX SCREWDRIVER BIT STERILE DRIVER PIN HXX TORNIER S.A.S. 6014AV 03700386943775

    Patients

    Seq Age Sex Outcome Treatment
    1 Other