BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOX

    MDR report key: 14051010 · Received April 8, 2022

    Report

    Report Number
    1038671-2022-00389
    Event Type
    Injury
    Date Received
    April 8, 2022
    Date of Event
    March 9, 2022
    Report Date
    September 21, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862079473
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICE(S): 308-02-06, 6962186 - 6X120MM DISTAL STEM MODULAR CEMENTED. 308-05-17, 6486068 - DISTAL FIXATION RING HA 17.5. 308-08-00, 6842253 - XS PROX BODY +0. 308-15-01, 7037402 - TAPER LOCKING SCREW 0. 300-21-00, 6248129 - 0MM FIXED ANGLED KIT. 320-42-10, 5874247 - EQUINOXE REVERSE 42MM HUMERAL CONST LINER +0. 320-10-10, 7045815 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10.

    Additional Manufacturer Narrative · 0

    SECTION H10: H3: THE INCORRECT SCREW IMPLANTATIONS REPORTED WERE LIKELY THE RESULT OF THE SALES REPRESENTATIVE MISTAKENLY OPENING THE INCORRECT TORQUE SCREW BOXES DURING EACH CASE, WHICH LED TO IMPLANTATION OF ANATOMIC TORQUE DEFINING SCREWS IN REVERSE HUMERAL TRAYS. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: B5: IT WAS REPORTED THAT AN ATSA TORQUE DEFINING SCREW WAS USED WITH A +10MM HUMERAL TRAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT WAS REVISED DUE TO THE SURGEON IMPLANTING AN ANATOMIC SCREW IN A REVERSE TRAY. ANATOMIC TORQUE SCREWS WERE THEN USED WITH REVERSE HUMERAL TRAYS (ONE +10 AND ONE +15).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ATSA TORQUE DEFINING SCREW WAS USED WITH A +10MM HUMERAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155740 EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT KWT EXACTECH, INC. 300-20-02 UNK 10885862079473

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R SEE H10