MAUDE Adverse Event Report: CORIN LTD TRINITY; TRINITY STD INTRODUCER / IMPACTOR HANDLE

Model Number 921.129

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  malfunction  

Event Description

During surgery, the trinity handle and cup could not be disengaged.Subsequently, the thread of the introducer handle broke.This led to a 30 minute surgical delay but there was no reported patient impact.

Manufacturer Narrative

Case-2022-1433 initial report.Additional information, including the device lot code 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 has been requested and once provided 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.

Manufacturer Narrative

(b)(4) final report additional information including the device lot code and the part no.And lot code of the associated trinity cup was requested and provided.The reporter stated that they could not determine the details of the cup that was used in this event as there had been 2 trinity procedures at that hospital on the day of the event, thus the part no.And lot code of the cups used in both these surgeries were provided.The appropriate device details were provided and the relevant device manufacturing records for the trinity std introducer / impactor handle and trinity cup have been identified and reviewed.These parts were manufactured to the correct specifications at the time of manufacture.This failure mode has been reported to corin previously and because of the feedback from the field an investigation has been initiated to investigate this failure and research a new design.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.

• Brand Name: TRINITY
• Type of Device: TRINITY STD INTRODUCER / IMPACTOR HANDLE
• Manufacturer (Section D): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester; gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 17255652
• MDR Text Key: 318498415
• Report Number: 9614209-2023-00200
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 921.129
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/06/2023
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 06/06/2023
• Supplement Dates FDA Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TRINITY CUP 321.03.350, 526006; TRINITY CUP 321.03.350, 526591