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

Model Number 921.129G

Device Problems Separation Failure (2547); Insufficient Information (3190)

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

Event Date 11/25/2021

Event Type  malfunction  

Manufacturer Narrative

Initial report: the reported handle and cup are being returned to corin uk and will be reviewed.Details of the 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.

Event Description

It was reported that a trinity cup could no longer be removed from the trinity std introducer / impactor handle.It was later stated on 10-dec-2021 that this occurred during impaction of the cup and thus the already impacted cup was removed and an alternative device was located and implanted with an alternative handle.

Manufacturer Narrative

Per -4335 final report, the reported handle and cup were returned to corin uk and have been reviewed.The reported failure mode was confirmed.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 a project has been initiated to research a new design for this instrument 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.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

It was reported that a trinity cup could no longer be removed from the trinity std introducer / impactor handle.It was later stated on (b)(6) 2021 that this occurred during impaction of the cup and thus the already impacted cup was removed and an alternative device was located and implanted with an alternative handle.

• 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: marie-anne euzen ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 12975089
• MDR Text Key: 285345577
• Report Number: 9614209-2021-00141
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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,Followup
• Report Date: 02/15/2022

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: 921.129G
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 078967-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 11/26/2021
• Supplement Dates FDA Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2018
• 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
• Treatment: TRINITY CUP: 321.03.052, 477232; TRINITY CUP: 321.03.052, 477232