BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 23449954 · Received November 3, 2025

    Report

    Report Number
    9614209-2025-00597
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 21, 2025
    Report Date
    January 15, 2026
    Manufacturer
    CORIN LTD
    Product Code
    LWJ
    UDI-DI
    05055343865224
    PMA / PMN Number
    K110087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER (B)(4) FINAL REPORT. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACATURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. REVIEW OF THESE RECORDS REVEALED NO PRODUCT NON-CONFORMITY OR DEVIATION FROM PROCESS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED DEVICES WERE RETURNED AND EXAMINED. THE THREADS OF BOTH THE HANDLE AND SHELL WERE EXAMINED AND SOME SLIGHT BURRING WAS OBSERVED ON THE THREAD OF THE HANDLE BUT NO DAMAGE WAS SEEN ON THE THREAD OF THE SHELL. IT IS POSSIBLE THAT THE WEAR SEEN ON THE THREAD OF THE HANDLE LED TO THE EVENT EXPERIENCED BY THE REPORTER, HOWEVER, THE FAILURE COULD NOT BE REPLICATED WITH A FUNCTIONAL TEST AT CORIN UK. POSSIBLE TO BE WEAR AND TEAR FROM THE HANDLE THAT LED TO THE EVENT, THUS THIS CASE IS NOW CONSIDERED CLOSED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    PER (B)(4) INITIAL REPORT. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. THE REPORTED DEVICES ARE BEING RETURNED FOR EXAMINATION AND DETAILS OF THIS EXAMINATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    TRINITY STD INTRODUCER / IMPACTOR HANDLE: STUCK TO TRINITY SHELL INTRA-OPERATIVELY.

    Description of Event or Problem · 0

    TRINITY STD INTRODUCER/IMPACTOR HANDLE: STUCK TO TRINITY SHELL INTRA-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798182 TRINITY STD INTRODUCER / IMPACTOR HANDLE LWJ CORIN LTD 921.129 404553-06 05055343865224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R TRINITY CUP: 321.05.360, 573236