BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI GLENOID-PERIPHERAL LOCK SCRW

    MDR report key: 16086905 · Received January 3, 2023

    Report

    Report Number
    1220246-2023-06016
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    December 9, 2022
    Report Date
    June 6, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867057753
    PMA / PMN Number
    K142863
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    501

    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

    THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER PROVIDED PHOTO, WHICH DISPLAYS THE DISTAL END ON THE IMPLANT HAD BROKEN AND DAMAGED THREADS. HOWEVER, WITHOUT THE RETURN OF THE DEVICE FOR PHYSICAL EVALUATION, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE, MISALIGNED INSERTION AND/OR PRYING/LEVERAGING THE DEVICE DURING USE.

    Description of Event or Problem · 0

    ON 12/15/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE BY EMAIL THAT A AR-9145-48 UNIVERSAL GLENOID LOCKING SCREW BROKE WHEN BEING DRIVEN INTO A GLENOID. THIS WAS DISCOVERED DURING AN ECLIPSE TSA W/ CONVERTIBLE UNIVERSAL GLENOID ON (B)(6) 2022. THE TIP WAS REMOVED, BUT THE REMAINDER OF THE SCREW WAS LEFT IN THE PATIENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 12/15/22: THE PROCEDURE WAS COMPLETED BY SHAVING DOWN THE TIP OF THE SUPERIOR BROKEN SCREW ON THE UNIVERSAL BASEPLATE THAT WAS IMPEDING THE INLAY POLY FROM SEATING. THE CENTRAL AND INFERIOR PERIPHERAL SCREWS WERE IMPLANTED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191496 UNI GLENOID-PERIPHERAL LOCK SCRW SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW 170167313 00888867057753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown