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

Model Number 921.129

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Per (b)(4) combined report.No adverse event or patient impact has been reported.However, the location of the broken part of the thread is unknown.The appropriate device details were provided and the relevant device manufacturing record has been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.This failure mode has been reported to corin previously and as a result of the feedback from the field, corin has initiated a project to research a new design for this instrument, including a new thread and 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.

Event Description

It was reported that the thread of a trinity handle had "sheared off" during surgery.The location of the broken part of the thread is unknown.

• Brand Name: TRINITY
• Type of Device: STD INTRODUCER / IMPACTOR HANDLE
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester; gloucestershire, GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; 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: 9877829
• MDR Text Key: 190901354
• Report Number: 9614209-2020-00032
• 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
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 921.129
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 078758-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Date Manufacturer Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1