BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNI GLENOID-PERIPHERAL LOCK SCRW

    MDR report key: 10515529 · Received September 10, 2020

    Report

    Report Number
    1220246-2020-02144
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    August 25, 2020
    Report Date
    September 10, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867057746
    PMA / PMN Number
    K142863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A UNIVERSAL GLENOID PROCEDURE TWO AR-9145-42, UNI GLENOID PERIPHERAL LOCKING SCREWS (LOT 18.00584) BROKE DURING INSERTION. BOTH SCREWS BROKE FROM THE HEAD AS THE SURGEON TRIED TO RETRIEVE THEM, SMALL PIECES KEPT BREAKING OFF. THE SURGEON PROCEEDED TO REMOVE THE CENTRAL SCREW ALONG WITH THE BASE PLATE AND LEFT ABOUT HALF TO A QUARTER OF THE SCREW IN THE PATIENT AS THE PORTION COULD NOT BE RETRIEVED. THE SURGEON HAD TO CHANGE THE TECHNIQUE FROM A UNIVERSAL GLENOID TO A REVERSE MODULAR GLENOID . IN ORDER TO MAKE THE CHANGE THE SURGEON ALSO HAD TO REMOVE THE FOLLOWING DEVICES (QUANTITY ONE EACH) WHICH HAD JUST BEEN IMPLANTED: AR-9165-25 UNIVERSAL GLENOID CENTRAL SCREW (LOT 18.01267), AR-9145-24 UNIVERSAL GLENOID PERIPHERAL LOCKING SCREW (LOT 18.02031) AND AR-9120-03 UNIVERSAL GLENOID BASEPLATE (LOT 170014815). PATIENT BONE QUALITY WAS REPORTED TO BE GOOD AND HARD. THE PATIENT WAS A YOUNG MALE. REPORTER STATES THE SURGEON USED THE PROPER IMPLANT TECHNIQUE WITH THE PROPER DRILL BIT. ALL SCREWS WERE DISPOSED OF AT TIME OF PROCEDURE. BASEPLATE WAS KEPT TO RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981693 UNI GLENOID-PERIPHERAL LOCK SCRW SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW 18.00584 00888867057746

    Patients

    Seq Age Sex Outcome Treatment
    1 Other