BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEQUALIS REVERSED HEX SCREW DRIVER BIT D3.5MM L25MM

    MDR report key: 11986608 · Received June 11, 2021

    Report

    Report Number
    3000931034-2021-00277
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    April 7, 2021
    Report Date
    June 11, 2021
    Manufacturer
    TORNIER S.A.S.
    Product Code
    HTW
    UDI-DI
    03700386943775
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS NECESSARY TO REMOVE THE REVERSE SHOULDER PROSTHESIS FROM THE PATIENT. AN (B)(6)YEAR-OLD WITH MILD-GRADE DIABETES THAT PRESENTED INFECTION WITH INDICATION FOR REMOVING THE PROSTHESIS. DURING THE SURGERY, ON (B)(6) 2021, THE PART OF THE HUMERUS IMPLANT WAS REMOVED WITHOUT PROBLEMS, FOLLOWED BY THE REMOVAL OF THE GLENOID IMPLANTS. AT THIS STAGE OF THE PROCEDURE, THE FOLLOWING EVENTS WERE REGISTERED: CONTAMINATION OF THE HEXAGONAL SCREWDRIVER, DWD167 AND REPLACEMENT WITH ANOTHER SCREWDRIVER OF THE SAME MODEL SUITABLE FOR FITTING. WITH THE SPARE SCREWDRIVER, THE SURGEON UNSUCCESSFULLY ATTEMPTED TO REMOVE THE GLENOID WITH NORMAL FORCE. SURGEON MADE ANOTHER ATTEMPT, NOW WITH THE GREATEST FORCE, CAUSING THE TIP OF THE SCREWDRIVER BREAK INSIDE THE ORIFICE OF THE GLENOSPHERE. THE TIP OF THE SCREWDRIVER REMAINS INSIDE THE PATIENT WITH THE ASSEMBLY OF THE GLENOSPHERE ON THE GLENOID BASE PLATE. THE DOCTOR FINISHED THE PROCEDURE WITHOUT REMOVING THE PROSTHESIS. NO, THERE WAS NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877950 AEQUALIS REVERSED HEX SCREW DRIVER BIT D3.5MM L25MM SURGICAL SCREWDRIVER HTW TORNIER S.A.S. DIAM 3.5MM LENGTH 25MM 7524AR 03700386943775

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other