BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 19687721 · Received July 8, 2024

    Report

    Report Number
    9614209-2024-00353
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    June 24, 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
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FINAL REPORT. ADDITIONAL INFORMATION, INCLUDING THE PART NO. AND LOT CODE OF THE ASSOCIATED TRINITY ACETABULAR SHELL, A PHOTOGRAPH OF THE REPORTED SCREW, WHY THE REPORTED SCREW IS NOT ABLE TO BE RETURNED FOR EXAMINATION, WHETHER ALL BROKEN PARTS OF THE SCREW WERE LOCATED AND REMOVED FROM THE JOINT SPACE, WHETHER IT WAS POSSIBLE THAT ANY BROKEN PART OF THE SCREW REMAINED IN THE PATIENT, POST-OP X-RAYS, OPERATIVE NOTES, WERE TRINITY INSTRUMENTS USED TO PREPARE THE SCREW HOLES, WAS THE CORRECT ANGULATION (AS PER THE CORIN TRINITY OPERATIVE TECHNIQUE) USED WHEN INSERTING THE SCREW, WAS THE SHELL FULLY IMPACTED WITHIN THE ACETABULUM PRIOR TO THE INSERTION OF THE SCREW, WHETHER THE SURGEON WAS SATISFIED WITH THE FIXATION OF THE SHELL AND OUTCOME OF THE SURGERY AND AN UPDATE ON THE PATIENT POST-OP WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT. THE REPORTER CONFIRMED THAT ALL BROKEN PARTS OF THE SCREW WERE RETRIEVED AND NONE WERE LEFT IN THE PATIENT. THE BROKEN SCREW WAS THEN DISCARDED OF AFTER SURGERY. OPERATIVE NOTES AND X-RAYS COULD NOT BE PROVIDED. 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 AVAILABLE INFORMATION, NO FURTHER INVESTIGATION CAN BE CONDUCTED, AND THE ROOT CAUSE OF THE SCREW FRACTURE COULD NOT BE DETERMINED. THIS CASE IS NOW CONSIDERED CLOSED, HOWEVER, SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED THEN THIS CASE MAY BE RE-OPENED FOR FURTHER 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.

    Additional Manufacturer Narrative · 0

    PER -(B)(4) INITIAL REPORT. ADDITIONAL INFORMATION, INCLUDING THE PART NO. AND LOT CODE OF THE ASSOCIATED TRINITY ACETABULAR SHELL, A PHOTOGRAPH OF THE REPORTED SCREW, WHY THE REPORTED SCREW IS NOT ABLE TO BE RETURNED FOR EXAMINATION, WHETHER ALL BROKEN PARTS OF THE SCREW WERE LOCATED AND REMOVED FROM THE JOINT SPACE, WHETHER IT WAS POSSIBLE THAT ANY BROKEN PART OF THE SCREW REMAINED IN THE PATIENT, POST-OP X-RAYS, OPERATIVE NOTES, WERE TRINITY INSTRUMENTS USED TO PREPARE THE SCREW HOLES, WAS THE CORRECT ANGULATION (AS PER THE CORIN TRINITY OPERATIVE TECHNIQUE) USED WHEN INSERTING THE SCREW, WAS THE SHELL FULLY IMPACTED WITHIN THE ACETABULUM PRIOR TO THE INSERTION OF THE SCREW, WHETHER THE SURGEON WAS SATISFIED WITH THE FIXATION OF THE SHELL AND OUTCOME OF THE SURGERY AND AN UPDATE ON THE PATIENT POST-OP HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, AND ID RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORD 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

    TRINITY CANCELLOUS BONE SCREW: PART OF THE METAL SHAVED OFF THE SCREW HEAD WHEN INSERTING INTO THE TRINITY SHELL.

    Description of Event or Problem · 0

    TRINITY CANCELLOUS BONE SCREW: PART OF THE METAL SHAVED OFF THE SCREW HEAD WHEN INSERTING INTO THE TRINITY SHELL..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193298 TRINITY ACETABULAR HIP SYSTEM LZO CORIN LTD 321.020 550479

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TRINITY ACETABULAR SHELL: 321.03.350, 552297.| TRINITY ACETABULAR SHELL: DEVICE DETAILS UNKNOWN.