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

Model Number	921.129
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Trinity std introducer/impactor handle: stuck to trinity shell intra-operatively.
Additional Manufacturer Narrative
Per (b)(4) initial report.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.The reported devices are being returned for examination and details of this 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 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 or Problem Description
Trinity std introducer / impactor handle: stuck to trinity shell intra-operatively.
Additional Manufacturer Narrative
Per (b)(4) final report.The appropriate device details were provided and the relevant device manufacaturing records have been identified and reviewed.Review of these records revealed no product non-conformity or deviation from process that would have caused or contributed to the reported event.The reported devices were returned and examined.The threads of both the handle and shell were examined and some slight burring was observed on the thread of the handle but no damage was seen on the thread of the shell.It is possible that the wear seen on the thread of the handle led to the event experienced by the reporter, however, the failure could not be replicated with a functional test at corin uk.Possible to be wear and tear from the handle that led to the event, thus this case is now considered closed.Please note: this report is filed with the fda due to an 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
• Common Device Name: 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: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 23449954
• Report Number: 9614209-2025-00597
• Device Sequence Number: 9008038
• Product Code: LWJ
• UDI-Device Identifier: 05055343865224
• UDI-Public: 05055343865224
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 921.129
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 404553-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRINITY CUP: 321.05.360, (B)(6).; TRINITY CUP: 321.05.360, (B)(6).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown