BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS VAULTLOCK GLENOID TRIAL, MEDIUM

    MDR report key: 12569513 · Received October 4, 2021

    Report

    Report Number
    1220246-2021-03723
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 13, 2021
    Report Date
    October 4, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867250680
    PMA / PMN Number
    K161108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    ON 09/14/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9202-10 SCREWDRIVER WAS MISSING AND AN AR-9236-02PP GLENOID TRIAL WAS BROKEN. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE. REP CONTACTED ON 9/15 FOR MORE INFORMATION. ADDITIONAL INFORMATION: REP RETURNED CONTACT ON 9/15, CONFIRMED SINGLE PROCEDURE ON (B)(6) 2021. THE BATCH OF THE MISSING DEVICE COULD NOT BE OBTAINED. THE AR-9236-02PP HAD A PLUG BREAK OF INSIDE THE PATIENT. THE PLUG WAS SUCCESSFULLY REMOVED AND THE CASE CONTINUED WITH NO FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464381 UNIVERS VAULTLOCK GLENOID TRIAL, MEDIUM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. UNIVERS VAULTLOCK GLENOID TRIAL, MEDIUM 1027261811 00888867250680

    Patients

    Seq Age Sex Outcome Treatment
    1