BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 19103408 · Received April 15, 2024

    Report

    Report Number
    9614209-2024-00315
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    April 2, 2024
    Report Date
    June 17, 2024
    Manufacturer
    CORIN LTD
    Product Code
    LZO
    PMA / PMN Number
    K122305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL REPORT. THE REPORTED DEVICES ARE BEING RETURNED TO CORIN AND WILL BE EXAMINED. DETAILS OF THIS REVIEW WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. 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 -5768 FINAL REPORT THE REPORTED TRINITY INTRODUCER HANDLE AND TRINITY ACETABULAR SHELL WERE RETURNED FOR EXAMINATION. THE FAILURE MODE WAS CONFIRMED, HOWEVER, AFTER A FEW IMPACTIONS THE SHELL COULD BE REMOVED FROM THE HANDLE. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. ALL PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. HOWEVER, TRENDING HAS IDENTIFIED THAT THIS COULD BE A USER ISSUE. CORIN WILL CONTINUE TO MONITOR TRENDS RELATING TO THIS OR SIMILAR FAILURE MODES AND 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 ONCE THE TRINITY ACETABULAR SHELL WAS IMPACTED IN THE ACETABULUM, IT COULD NOT BE DETACHED FROM THE TRINITY INTRODUCER HANDLE. THE IMPACTED SHELL WAS REMOVED AND ALTERNATIVES USED. THIS CAUSED A DELAY TO SURGERY OF MORE THAN 30 MINUTES.

    Description of Event or Problem · 0

    DURING SURGERY ONCE THE TRINITY ACETABULAR SHELL WAS IMPACTED IN THE ACETABULUM, IT COULD NOT BE DETACHED FROM THE TRINITY INTRODUCER HANDLE. THE IMPACTED SHELL WAS REMOVED AND ALTERNATIVES USED. THIS CAUSED A DELAY TO SURGERY OF MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509472 TRINITY TRINITY-I ACETABULAR SHELL LZO CORIN LTD 321.02.346 524504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention TRINITY INTRODUCER HANDLE: 9210129, 095751-05| TRINITY INTRODUCER HANDLE: 9210129, 095751-05