BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS VAULTLOCK GLENOID TRIAL, LARGE

    MDR report key: 19595947 · Received June 24, 2024

    Report

    Report Number
    1220246-2024-06382
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    May 29, 2024
    Report Date
    January 23, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867250697
    PMA / PMN Number
    K161108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED CANNULATED DRILL BIT LOT NUMBER: 032321 THAT IS PART OF AN AR-9928BCK-MIS MINI-OPEN FIBERTAK® ACHILLES SPEEDBRIDGE¿ REPAIR IMPLANT SYSTEM LOT NUMBER: 15222869 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT THE TIP OF THE DEVICE WAS BROKEN AND A FRAGMENT WAS MISSING. DIMENSIONAL TESTING WAS PERFORMED USING A CALIPER ID: 1003729. THE LENGTH OF THE DEVICE WAS MEASURED AND FOUND TO BE 3.330, INDICATING THAT THE MISSING FRAGMENT IS AROUND .050, AS THE LENGTH DIMENSION SPECIFIED IN DRAWING C20663 REV 8 IS 3.380. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO MISALIGNED INSERTION AND/OR PRYING/LEVERAGING THE DEVICE DURING USE.

    Description of Event or Problem · 0

    ON 05/29/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-03PP UNIVERS VAULTLOCK¿ GLENOID TRIALS CENTRAL PEG SNAPPED OFF. THIS OCCURRED DURING A TSA PROCEDURE ON (B)(6) 2024 THE CASE WAS CARRIED ON SUCCESSFULLY AND THE BROKEN PEG WAS RETRIEVED FROM THE PATIENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED ON 6/3/2024 WHERE THE SALES REPRESENTATIVE STATED THAT THE DEVICE FAILED DURING REMOVAL. AFTER INSERTING IN TO THE GLENOID AND TRIALING, IT BROKE WHEN THE SURGEON WAS TRYING TO TAKE IT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2182193 UNIVERS VAULTLOCK GLENOID TRIAL, LARGE ORTHOPEDIC MANUAL SURG INSTR KWS ARTHREX, INC. UNIVERS VAULTLOCK GLENOID TRIAL, LARGE 1027261621 00888867250697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown