MAUDE Adverse Event Report: CORIN LTD (UK & FR) TRINITY; STD INTRODUCER/IMPACTOR HANDLE

Model Number 921.129

Device Problem Failure to Disconnect (2541)

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

Event Date 01/04/2024

Event Type  malfunction  

Event Description

Trinity evo cup became stuck to impactor handle during impaction.The implanted device had to be removed.

Manufacturer Narrative

(b)(4).Initial report: the appropriate device details were provided.The manufacturing records will be identified and reviewed.The devices were returned to corin, the results of the examination of these devices will be made available in a supplemental report.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: STD INTRODUCER/IMPACTOR HANDLE
• Manufacturer (Section D): CORIN LTD (UK & FR); 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: 18621992
• MDR Text Key: 334315535
• Report Number: 9614209-2024-00287
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/01/2024

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: 082766-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Distributor Facility Aware Date: 01/04/2024
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TRINITY EVO CUP, BO76.3244.000.00, 2010284/009
• Patient Outcome(s): Other