BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEQUALIS REVERSED HEX SCREWDRIVER BIT

    MDR report key: 11633045 · Received April 8, 2021

    Report

    Report Number
    3000931034-2021-00031
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 10, 2021
    Report Date
    March 10, 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.

    Description of Event or Problem · 1

    DURING SURGERY THE TIP OF THE SCREWDRIVER BROKE OFF IN THE PATIENT'S GLENOSPHERE. THE TIP WAS FIRMLY EDGED IN THE GLENOSPHERE AND THE TIP WAS FLUSH. THE TIP WAS LEFT INSIDE THE PATIENT AS IT COULDN'T BE REMOVED DESPITE SEVERAL ATTEMPTS USING DIFFERENT METHODS BY THE SURGEON (FRAZIER SUCKER, DENTAL PICK, DRILLING AND BURRING). AS A PRECAUTION THE SURGEON PLACED BONE WAX IN THE HOLE IN THE GLENOSPHERE OVER THE BROKEN TIP TO PREVENT THE PIECE MOVING IF IT CAME LOOSE LATER. THE SURGEON HAS REQUESTED ADVICE FROM THE MANUFACTURER AS TO WHETHER THERE IS ANY WAY TO REMOVE THE BROKEN SCREWDRIVER TIP IF THE PATIENT REQUIRES A FUTURE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531193 AEQUALIS REVERSED HEX SCREWDRIVER BIT HEXAGONAL SCREWDRIVER TIP HXX TORNIER S.A.S. 03700386971006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other