BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 17255652 · Received July 5, 2023

    Report

    Report Number
    9614209-2023-00200
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 6, 2023
    Report Date
    September 4, 2023
    Manufacturer
    CORIN LTD
    Product Code
    LWJ
    PMA / PMN Number
    K093472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CASE-2022-1433 INITIAL REPORT. ADDITIONAL INFORMATION, INCLUDING THE DEVICE LOT CODE HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS HAS BEEN REQUESTED AND ONCE PROVIDED THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. 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) FINAL REPORT ADDITIONAL INFORMATION INCLUDING THE DEVICE LOT CODE AND THE PART NO. AND LOT CODE OF THE ASSOCIATED TRINITY CUP WAS REQUESTED AND PROVIDED. THE REPORTER STATED THAT THEY COULD NOT DETERMINE THE DETAILS OF THE CUP THAT WAS USED IN THIS EVENT AS THERE HAD BEEN 2 TRINITY PROCEDURES AT THAT HOSPITAL ON THE DAY OF THE EVENT, THUS THE PART NO. AND LOT CODE OF THE CUPS USED IN BOTH THESE SURGERIES WERE PROVIDED. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS FOR THE TRINITY STD INTRODUCER / IMPACTOR HANDLE AND TRINITY CUP HAVE BEEN IDENTIFIED AND REVIEWED. THESE PARTS WERE MANUFACTURED TO THE CORRECT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS FAILURE MODE HAS BEEN REPORTED TO CORIN PREVIOUSLY AND BECAUSE OF THE FEEDBACK FROM THE FIELD AN INVESTIGATION HAS BEEN INITIATED TO INVESTIGATE THIS FAILURE AND RESEARCH A NEW DESIGN. 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.

    Description of Event or Problem · 0

    DURING SURGERY, THE TRINITY HANDLE AND CUP COULD NOT BE DISENGAGED. SUBSEQUENTLY, THE THREAD OF THE INTRODUCER HANDLE BROKE. THIS LED TO A 30 MINUTE SURGICAL DELAY BUT THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459343 TRINITY TRINITY STD INTRODUCER / IMPACTOR HANDLE LWJ CORIN LTD 921.129 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TRINITY CUP 321.03.350, 526006| TRINITY CUP 321.03.350, 526591