BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 19308096 · Received May 14, 2024

    Report

    Report Number
    9614209-2024-00323
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    March 4, 2024
    Report Date
    July 17, 2024
    Manufacturer
    CORIN LTD
    Product Code
    LZO
    PMA / PMN Number
    K093472
    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. ADDITIONAL INFORMATION INCLUDING WERE TRINITY INSTRUMENTS USED TO PREP THE SCREW HOLES, WAS THE CORRECT ANGULATION (AS PER THE CORIN TRINITY OP TECH) USED WHEN INSERTING THE SCREW, WAS THE SHELL FULLY IMPACTED WITHIN THE ACETABULUM PRIOR TO THE INSERTION OF THE SCREW, PART NO. AND LOT CODE OF THE IMPLANTED TRINITY SHELL, POST-OP X-RAYS, WAS THE BROKEN SCREW LEFT IN THE PATIENT'S ACETABULUM, WAS THE PART OF THE SCREW THAT BROKE OFF LOCATED AND REMOVED FROM THE WOUND, IS IT POSSIBLE THAT ANY BROKEN PARTS OF THE SCREW REMAINED IN THE JOINT SPACE, WAS THE SURGEON SATISFIED WITH THE FIXATION OF THE CUP, WERE ADDITIONAL SCREWS USED, IS THE PATIENT SCHEDULED FOR ANY ADDITIONAL FOLLOW-UP, DID THE EVENT CAUSE A SURGICAL DELAY OR IMPACT TO THE PATIENT AND WHETHER THE SCREW AVAILABLE TO RETURN FOR EXAMINATION 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 OF THE SCREW 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.

    Additional Manufacturer Narrative · 0

    (B)(4) FINAL REPORT. ADDITIONAL INFORMATION INCLUDING WERE TRINITY INSTRUMENTS USED TO PREP THE SCREW HOLES, WAS THE CORRECT ANGULATION (AS PER THE CORIN TRINITY OP TECH) USED WHEN INSERTING THE SCREW, WAS THE SHELL FULLY IMPACTED WITHIN THE ACETABULUM PRIOR TO THE INSERTION OF THE SCREW, PART NO. AND LOT CODE OF THE IMPLANTED TRINITY SHELL, POST-OP X-RAYS, WAS THE BROKEN SCREW LEFT IN THE PATIENT'S ACETABULUM, WAS THE PART OF THE SCREW THAT BROKE OFF LOCATED AND REMOVED FROM THE WOUND, IS IT POSSIBLE THAT ANY BROKEN PARTS OF THE SCREW REMAINED IN THE JOINT SPACE, WAS THE SURGEON SATISFIED WITH THE FIXATION OF THE CUP, WERE ADDITIONAL SCREWS USED, IS THE PATIENT SCHEDULED FOR ANY ADDITIONAL FOLLOW-UP, DID THE EVENT CAUSE A SURGICAL DELAY OR IMPACT TO THE PATIENT AND WHETHER THE SCREW AVAILABLE TO RETURN FOR EXAMINATION WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, HOWEVER, NONE OF THIS INFORMATION WAS PROVIDED AND THUS THE SCOPE OF THE INVESTIGATION WAS VERY LIMITED. THE APPROPRIATE DEVICE DETAILS OF THE SCREW 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, NO FURTHER INVESTIGATION CAN BE CONDUCTED AND THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THIS CASE IS THEREFORE, 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.

    Description of Event or Problem · 0

    CORIN RECEIVED A REPORT REGARDING A TRINITY BONE SCREW THAT BROKE DURING USE.

    Description of Event or Problem · 0

    CORIN RECEIVED A REPORT REGARDING A BROKEN TRINITY SCREW THAT BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598867 TRINITY CANCELLOUS BONE SCREW LZO CORIN LTD 321.030 549742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown