BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUINOXE

    MDR report key: 12562475 · Received October 1, 2021

    Report

    Report Number
    1038671-2021-00503
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    September 9, 2021
    Report Date
    April 7, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    UDI-DI
    10885862086518
    PMA / PMN Number
    K063569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) THE TORQUE DEFINING SCREW ISSUE REPORTED MAY HAVE BEEN THE RESULT OF THE SURGEON APPLYING AN OFF-AXIS TWISTING FORCE TO THE TORQUE SCREW WHEN ATTEMPTING TO TORQUE TO 11 N-M, WHICH RESULTED IN THE SCREW HEAD BREAKING IMPROPERLY.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 300-01-09, 6970020 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM. 320-10-00, 6919275 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-38-00, S274758 - EQUINOXE REVERSE 38MM HUMERAL LINER +0.

    Description of Event or Problem · 1

    AS REPORTED, DURING SET-UP FOR A REVERSE SHOULDER SURGERY, THE PREPARATION STEPS TOOK PLACE AS USUAL. WHILE PREPARING THE ASSEMBLY OF THE ELEMENTS ( FIXATION OF THE HUMERAL ADAPTOR ON HUMERAL STEM) THE HEAD OF THE SCREW BROKE INCORRECTLY , WHICH MADE THE LINER IMPLEMENTATION IMPOSSIBLE. DEVICES WERE NOT USED AND THE OUTCOME OF THIS WAS THE CUSTOMER RETURNED OTHER IMPLANTS & SENT BACK TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458597 EQUINOXE REVERSE TORQUE DEFINING SCREW KIT LXH EXACTECH, INC. 320-20-00 UNK 10885862086518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R