BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 20178199 · Received September 10, 2024

    Report

    Report Number
    9614209-2024-00376
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    August 29, 2024
    Report Date
    November 27, 2024
    Manufacturer
    CORIN LTD
    Product Code
    LWJ
    PMA / PMN Number
    K110087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER -7691 INITIAL REPORT. THE REPORTED DEVICES ARE BEING RETURNED AND WILL BE EXAMINED. IT WAS STATED THAT THE DEVICE LOT CODE OF THE HANDLE WAS UNREADABLE, THIS WILL BE CHECKED UPON RECEIPT OF THE DEVICE. THE APPROPRIATE DEVICE DETAILS WILL BE CONFIRMED WHEN THE PARTS ARE RETURNED TO CORIN UK. THE RELEVANT DEVICE MANUFACTURING RECORDS WILL THEN BE IDENTIFIED AND REVIEWED. 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) FINAL REPORT. THE REPORTED DEVICES WERE RETURNED AND EXAMINED. THE REPORTED FAILURE WAS CONFIRMED. IT WAS STATED THAT THE DEVICE LOT CODE OF THE HANDLE WAS UNREADABLE, THIS WAS CHECKED UPON RECEIPT OF THE DEVICE AND THE LOT CODE IDENTIFIED. THE RELEVANT DEVICE MANUFACTURING RECORDS WERE 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. THIS FAILURE HAS BEEN REPORTED PREVIOUSLY AND AS A RESULT, A DESIGN CHANGE HAS BEEN IMPLEMENTED TO THE TRINITY HANDLE. THEREFORE, THIS CASE IS NOW CONSIDERED CLOSED. 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 STD INTRODUCER / IMPACTOR HANDLE COULD NOT DISENGAGE FROM THE TRINITY SHELL POST IMPACTION. THE SHELL WAS REMOVED AND AN ALTERNATIVE WAS LOCATED AND IMPLANTED WITH NO ISSUE.

    Description of Event or Problem · 0

    DURING SURGERY, THE TRINITY STD INTRODUCER / IMPACTOR HANDLE COULD NOT DISENGAGE FROM THE TRINITY SHELL POST IMPACTION. THE SHELL WAS REMOVED AND AN ALTERNATIVE WAS LOCATED AND IMPLANTED WITH NO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336168 TRINITY STD INTRODUCER / IMPACTOR HANDLE LWJ CORIN LTD 921.129G 085112-15

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TRINITY CUP: 324.02.546, 532059| TRINITY CUP: 324.02.546, 532059