MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; INTRODUCER HANDLE

Model Number 9210129

Device Problems Unexpected Therapeutic Results (1631); No Apparent Adverse Event (3189); Physical Resistance/Sticking (4012)

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

Event Date 10/21/2021

Event Type  malfunction  

Event Description

Trinity introducer handle: got stuck with the cup following impaction.Surgery was delayed (unknown time) whilst a new handle and cup were located.New cup implanted.

Manufacturer Narrative

(b)(4) initial report.Additional information, including the length of surgical delay has been requested, and if received, will be provided in a supplemental report upon completion of the investigation.The reported cup and handle are being returned to corin and will be examined upon receipt.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 an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

Event Description

Trinity introducer handle: got stuck with the cup following impaction.Surgery was delayed (unknown time) whilst a new handle and cup were located.New cup implanted.

Manufacturer Narrative

Per -4425 final report.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.Following feedback from the field, corin has initiated a project to research a new design for this instrument.Therefore, 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.

• Brand Name: TRINITY
• Type of Device: INTRODUCER 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: 13304405
• MDR Text Key: 288863394
• Report Number: 9614209-2022-00005
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 04/01/2022

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: 9210129
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 086396-09
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TRINITY PLUS CUP: 324.03.550, 479387; TRINITY PLUS CUP: 324.03.550, 479387