BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQ REVERSE TORQUE DEFINING SCREW KIT

    MDR report key: 15111191 · Received July 27, 2022

    Report

    Report Number
    1038671-2022-00849
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    July 6, 2022
    Report Date
    February 6, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086518
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING DEVICE EVALUATION. 320-42-13 / SN: 4502063 - EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5. 320-10-05 / SN: 4626208 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5. 320-01-42 / SN: 4061886 - EQUINOXE REVERSE 42MM GLENOSPHERE. 320-15-05 / SN: 4614860 - EQ REV LOCKING SCREW.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF INCOMPLETE SEATING/CROSS-THREADING OF THE REVERSE TORQUE DEFINING SCREW WITH THE HUMERAL STEM AND/OR AN UNREPORTED POST TRAUMATIC EVENT, WHICH ALLOWED THE TORQUE DEFINING SCREW TO BACK OUT AND RESULT IN THE REPORTED DISASSOCIATION OF THE HUMERAL TRAY FROM THE HUMERAL STEM.

    Description of Event or Problem · 0

    AS REPORTED, THIS 67 YEAR OLD, MALE PATIENT HAD A RIGHT RTSA PERFORMED ON (B)(6) 2016. SOMETIME BETWEEN THE ORIGINAL SURGERY AND (B)(6) 2022 THE PATIENT WAS REFERRED FOR A REVISION RTSA. THE RTSA PROSTHESIS WAS BEING REVISED BECAUSE THE TORQUE SCREW ATTACHING THE TRAY TO THE STEM BROKE CAUSING THE TRAY AND LINER TO BREAK COMPLETELY FROM THE STEM. THE SURGEON WAS ABLE TO LEAVE IN THE ORIGINAL STEM AND BASEPLATE/SCREWS AS THEY WERE WELL FIXATED. THE TRAY, TORQUE SCREW, LINER, GLENOSPHERE AND GLENOSPHERE LOCKING SCREW WERE REPLACED. THE HEAD OF THE TORQUE SCREW WAS UNABLE TO BE FOUND IN THE PATIENT WITH FLUOROSCOPY. THIS EVENT LED TO A 5-15 MINUTE SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667665 EQ REVERSE TORQUE DEFINING SCREW KIT PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. EQ REVERSE TORQUE DEFINING SCREW KIT 10885862086518

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention