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

Model Number 921.129G

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information, including length of surgical delay and an update on the patient post-surgery has been requested and if received 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.The submission of this report does not constitute that the device reporting entity, entty's representative or distributor caused or contributed to this event.

Event Description

Trinity std introducer / impactor handle would not disengage from the cup following impaction.The cup was well fixed but had to be removed due to it not being able to disengage from the handle.A new cup and handle were located and used to complete surgery.

Event Description

Trinity std introducer / impactor handle would not disengage from the cup following impaction.The cup was well fixed but had to be removed due to it not being able to disengage from the handle.A new cup and handle were located and used to complete surgery.

Manufacturer Narrative

Per -4723 final report.Additional information, including length of surgical delay and an update on the patient post-surgery was requested.It was confirmed that the surgical delay was approximately 10-15 minutes.The appropriate device details have been provided and the relevant device manufacturing records have been identified and reviewed.It was found that all finished 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 a new design for the trinity handle is currently being researched.Therefore, this case is now considered closed.The submission of this report does not constitute 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 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: dardan uka ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 14394754
• MDR Text Key: 300160037
• Report Number: 9614209-2022-00027
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/26/2022

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: 081571-18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 05/13/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TRINITY CUP: 321.04.356, 492503; TRINITY CUP: 321.04.356, 492503