BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEQUALIS REVERSED HEX SCREWDRIVER

    MDR report key: 11663380 · Received April 14, 2021

    Report

    Report Number
    3000931034-2021-00033
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 16, 2021
    Report Date
    March 16, 2021
    Manufacturer
    TORNIER S.A.S.
    Product Code
    HXX
    UDI-DI
    03700386971006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE FINAL 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.

    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

    WHEN INSERTING THE GLENOSPHERE THE DRIVER SNAPPED. EXCESSIVE FORCE WAS NOT USED. THE DRIVER HEAD WAS INSIDE THE GLENOSPHERE AND AFTER 5 MIN OF USING THE FRASER SUCKER AN X-RAY WAS CALLED TO CONFIRM IF IT WAS OUT. X RAY OF THE PATIENT SHOWED NO SIGN OF DRIVER HEAD. DR MACLEAN X RAYED THE SUCKER BAG AND THE DRIVER TIP WAS INSIDE. CONFIRMATION OF THE DRIVER TIP BEING OUT OF THE PATIENT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563304 AEQUALIS REVERSED HEX SCREWDRIVER HEXAGONAL SCREWDRIVER HXX TORNIER S.A.S. 03700386971006

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other