BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM

    MDR report key: 15550168 · Received October 6, 2022

    Report

    Report Number
    1038671-2022-01264
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    September 16, 2022
    Report Date
    March 10, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086549
    PMA / PMN Number
    K063569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 300-30-07, EQUINOXE PRESERVE STEM 7MM, 6960881, 315-35-00, GLND KWIRE, 6893917, 320-10-00, EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 A130292, 320-15-05, EQ REV LOCKING SCREW, A140142, 320-20-00, EQ REVERSE TORQUE DEFINING SCREW KIT, A122563, 320-20-22, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM, A085612, 320-20-30, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, A143906, 320-20-34, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM, A121955, A140900, 320-31-40, GLENOSPHERE, 40MM 7007760, 320-35-01, SMALL GLENOID PLATE A088033, 320-40-03, HUMERAL LINER, 40MM, +2.5 6168382, 531-78-20, SHOULDR GPS HEX PINS KIT, A116186.

    Additional Manufacturer Narrative · 0

    H3: THE FRACTURE OF THE COMPRESSION SCREW DURING IMPLANTATION REPORTED IN (B)(4) WAS MOST LIKELY THE RESULT OF APPLYING TORQUE GREATER THAN THE YIELD STRENGTH OF THE MATERIAL, POSSIBLY SECONDARY TO CONTRIBUTIONS FROM HARD BONE OR SEATING THE SCREW UNDER POWER.

    Description of Event or Problem · 0

    AS REPORTED, DURING SURGICAL USE, THE COMPRESSION SCREW BROKE WHILE THE SURGEON WAS IMPLANTING. THE BROKEN PORTION REMAINS IN THE PATIENT. NO ADVERSE EFFECTS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288210 EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 320-20-26 10885862086549

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other SEE H10