BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5X32MM PERIPHERAL SCREW, LOCKING

    MDR report key: 22009328 · Received May 13, 2025

    Report

    Report Number
    1220246-2025-02027
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 9, 2025
    Report Date
    June 9, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867296886
    PMA / PMN Number
    K173900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6 COMPLAINT ALLEGATION IS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. PER SURGICAL TECHNIQUE UNIVER REVERS MODULAR GLENOID SYSTEM - SCREW ANGULATION - NOTE: THE SCREW ANGULATION OF NONLOCKING (VARIABLE-ANGLE) AND LOCKING SCREWS CHANGES SLIGHTLY BASED ON THE CHOSEN BASEPLATE. FOR SPECIFIC ANGLES, REFERENCE THE CHART. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR DUE TO MISALIGNED INSERTION AND/OR EXCESSIVE MECHANICAL FORCES DURING USE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 04/16/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (QTY. 2) OF AN AR-9563-32 PERIPHERAL SCREW FAILED TO THREAD INTO THE BASEPLATE. TWO DIFFERENT LOCKING SCREWS FROM SEPARATE LOTS WERE ATTEMPTED, BUT NEITHER FIT. AS A RESULT, THE SURGEON OPTED FOR A NON-LOCKING SCREW TO COMPLETE THE PROCEDURE. NO COMPONENTS BROKE IN THE PATIENT. THIS WAS DISCOVERED DURING A REVERSE SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2300971 5.5X32MM PERIPHERAL SCREW, LOCKING SHOULDR PROSTH, REVERSE CONFIG PHX ARTHREX, INC. 5.5X32MM PERIPHERAL SCREW, LOCKING UNK 00888867296886

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown