MAUDE Adverse Event Report: CORIN LTD. TRINITY; ACETABULAR HIP SYSTEM (STD INTRODUCER / IMPACTOR HANDLE)

Model Number	921.129
Medical Device Problem Codes	Mechanical Jam (2983); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During total hip procedure.As the surgeon was implanting cup the screw in the cup impactor popped off.Not allowing the surgeon to remove the cup.Delaying case since cup was stuck on handle.
Additional Manufacturer Narrative
(b)(4) initial report.The reporter has confirmed the device is available for return.The appropriate device details have been provided, and the relevant device manufacturing records will be identified and reviewed.The submission of this report does not constitute an admission that the device reporting entities representative or distributer caused or contributed to this event.
Event or Problem Description
During total hip procedure.As the surgeon was implanting cup the screw in the cup impactor popped off.Not allowing the surgeon to remove the cup.Delaying case since cup was stuck on handle.
Additional Manufacturer Narrative
(b)(4) final report additional information including whether the surgeon re-reamed and implanted a larger than planned size cup was requested in order to progress with the investigation of this event, and were provided.It was confirmed that the surgery was delayed due to the devices getting stuck together.The devices were returned, where the failure was confirmed: these devices cannot be seperated.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.This failure has been reported to corin previously and as a result of feedback, a new handle has been released and thus this case is considered closed.The submission of this report does not constitute an admission that the device reporting entities representitive or distrubutercaused or contributed to this event.

• Brand Name: TRINITY
• Common Device Name: ACETABULAR HIP SYSTEM (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: 21890860
• Report Number: 9614209-2025-00485
• Device Sequence Number: 8146686
• Product Code: LWJ
• UDI-Device Identifier: 05055343865224
• UDI-Public: 05055343865224
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K093472
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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
• Operator of Device: Health Professional
• Device Model Number: 921.129
• Device Catalogue Number: N/A
• Device Lot Number: 286693-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2014
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRINITY CUP, DEVICE DETAILS UNKNOWN.; TRINITY CUP: 321.03.352, 505814.
• Patient Sex: Unknown