MAUDE Adverse Event Report: CORIN LTD TRINITY; TRINITY-I ACETABULAR SHELL

Model Number 321.02.346

Device Problem Insufficient Information (3190)

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

Event Date 04/02/2024

Event Type  malfunction  

Event Description

During surgery once the trinity acetabular shell was impacted in the acetabulum, it could not be detached from the trinity introducer handle.The impacted shell was removed and alternatives used.This caused a delay to surgery of more than 30 minutes.

Manufacturer Narrative

(b)(4) initial report.The reported devices are being returned to corin and will be examined.Details of this review will be provided in a supplemental report upon completion of the investigation.The appropriate device details 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 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

Per -5768 final report the reported trinity introducer handle and trinity acetabular shell were returned for examination.The failure mode was confirmed, however, after a few impactions the shell could be removed from the handle.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.Based on the available information, the root cause of the event could not be determined.However, trending has identified that this could be a user issue.Corin will continue to monitor trends relating to this or similar failure modes and 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.

Event Description

During surgery once the trinity acetabular shell was impacted in the acetabulum, it could not be detached from the trinity introducer handle.The impacted shell was removed and alternatives used.This caused a delay to surgery of more than 30 minutes.

• Brand Name: TRINITY
• Type of Device: TRINITY-I ACETABULAR SHELL
• 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: 19103408
• MDR Text Key: 340817890
• Report Number: 9614209-2024-00315
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122305
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2024

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: 321.02.346
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TRINITY INTRODUCER HANDLE: 9210129, 095751-05; TRINITY INTRODUCER HANDLE: 9210129, 095751-05
• Patient Outcome(s): Required Intervention