BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 19773190 · Received July 18, 2024

    Report

    Report Number
    9614209-2024-00357
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    May 16, 2024
    Report Date
    September 11, 2024
    Manufacturer
    CORIN LTD
    Product Code
    LZO
    PMA / PMN Number
    K093472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER -7102 FINAL REPORT: ADDITIONAL INFORMATION INCLUDING OPERATIVE NOTES, WHETHER TRINITY INSTRUMENTS WERE USED TO PREP THE SCREW HOLES, WHETHER THE SHELL WAS FULLY IMPACTED WITHIN THE ACETABULUM PRIOR TO THE INSERTION OF ANY SCREWS, WHETHER THE CORRECT ANGULATION (AS PER THE TRINITY OP TECH) USED WHEN IMPLANTING THE SCREWS, WHETHER THE PATIENT HAS EXPERIENCED ANY ISSUES POST-OP AND WHETHER THE SURGEON WILL HAVE ANY ADDITIONAL FOLLOW-UP WITH THE PATIENT WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT. THE REPORTER CONFIRMED THAT THE PATIENT WAS NOT EXPERIENCING ANY ISSUES AND WAS NOT SCHEDULED FOR ANY ADDITIONAL FOLLOW-UP. IT COULD NOT BE CONFIRMED WHETHER OR NOT THE CORRECT ANGULATION WAS USED AND IT WAS FOUND THAT THERE WAS A GAP POST-OP BETWEEN THE PATIENT'S ACETABULUM AND THE SHELL. 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. ADDITIONALLY, CORIN HAS NOT RECEIVED ANY OTHER REPORTS REGARDING DEVICES FROM THESE BATCHES. BASED ON THE ABOVE, NO FURTHER INVESTIGATION CAN BE CONDUCTED. IT HAS BEEN CONCLUDED THAT THE SCREW MOST LIKELY PULLED THROUGH THE SHELL INTRA-OPERATIVELY AS A RESULT OF THE SHELL NOT BEING FULLY IMPACTED WITHIN THE ACETABULUM PRIOR TO THE USE OF THE SCREW AS WELL AS POTENTIAL INCORRECT ANGULATION. 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. ADDITIONAL INFORMATION INCLUDING OPERATIVE NOTES, WHETHER TRINITY INSTRUMENTS WERE USED TO PREP THE SCREW HOLES, WHETHER THE SHELL WAS FULLY IMPACTED WITHIN THE ACETABULUM PRIOR TO THE INSERTION OF ANY SCREWS, WHETHER THE CORRECT ANGULATION (AS PER THE TRINITY OP TECH) USED WHEN IMPLANTING THE SCREWS, WHETHER THE PATIENT HAS EXPERIENCED ANY ISSUES POST-OP AND WHETHER THE SURGEON WILL HAVE ANY ADDITIONAL FOLLOW-UP WITH THE PATIENT 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 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 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

    AFTER SURGERY IT WAS IDENTIFIED THAT THE TRINITY CANCELLOS BONE SCREW HAD GONE THROUGH THE TRINITY ACETABULAR SHELL. THERE WAS NO REPORTED PATIENT IMPACT.

    Description of Event or Problem · 0

    AFTER SURGERY IT WAS IDENTIFIED THAT THE TRINITY CANCELLOS BONE SCREW HAD GONE THROUGH THE TRINITY ACETABULAR SHELL. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033858 TRINITY CANCELLOUS BONE SCREW LZO CORIN LTD 321.025 554743

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TRINITY ACETABULAR SHELL: 321.03.350, 551808| TRINITY ACETABULAR SHELL: 321.03.350, 551808| TRINITY CANCELLOUS BONE SCREW: 321.020, 558742| TRINITY CANCELLOUS BONE SCREW: 321.020, 558742