BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 17304430 · Received July 12, 2023

    Report

    Report Number
    9614209-2023-00204
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Date of Event
    June 24, 2023
    Report Date
    February 16, 2024
    Manufacturer
    CORIN LTD
    Product Code
    LWJ
    PMA / PMN Number
    K093472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FINAL REPORT IT HAS BEEN REPORTED THAT THERE WAS NO PATIENT IMPACT AS A RESULT OF THIS EVENT. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. IT WAS FOUND THAT ALL FINISHED PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. THE DEVICES WERE RETURNED TO CORIN AND EXAMINED. THE DEVICES WERE ABLE TO BE REMOVED BY HAND WITH EXCESSIVE FORCE AND DAMAGE WAS OBSERVED ON THE THREADS. THIS FAILURE HAS BEEN REPORTED TO CORIN PREVIOUSLY AND A NEW DESIGN IS BEING IMPLEMENTED TO THE TRINITY HANDLE. THEREFORE, THIS CASE IS NOW CONSIDERED CLOSED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE 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

    (B)(4). INITIAL REPORT. IT HAS BEEN REPORTED THAT THERE WAS NO PATIENT IMPACT AS A RESULT OF THIS EVENT. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. THE REPORTED DEVICES ARE BEING RETURNED TO CORIN AND WILL BE EXAMINED. DETAILS OF THE 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 ADVERSE 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

    2 TRINITY STD INTRODUCER / IMPACTOR HANDLES: GOT STUCK WITH THE TRINITY CUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794628 TRINITY TRINITY STD INTRODUCER / IMPACTOR HANDLE LWJ CORIN LTD 921.129 280480-02

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TRINITY CUP: 321.03.350, 514324.| TRINITY CUP: 321.03.350, 522725.| TRINITY HANDLE: 921.129, 201657-11.