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

Model Number 921.129

Device Problem Connection Problem (2900)

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

Event Date 06/24/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.It has been reported that there was no patient impact as a result of this event.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.The reported devices are being returned to corin and will be examined.Details of the examination will be provided in a supplemental report upon completion of the 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.

Event Description

2 trinity std introducer / impactor handles: got stuck with the trinity cups.

Manufacturer Narrative

(b)(4) final report it has been reported that there was no patient impact as a result of this event.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.It was found that all finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.The devices were returned to corin and examined.The devices were able to be removed by hand with excessive force and damage was observed on the threads.This failure has been reported to corin previously and a new design is being implemented to the trinity handle.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: 17304430
• MDR Text Key: 319760746
• Report Number: 9614209-2023-00204
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

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: 280480-02
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/26/2023
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 06/26/2023
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2014
• 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, 514324.; TRINITY CUP: 321.03.350, 522725.; TRINITY HANDLE: 921.129, 201657-11.