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

Model Number 921.129G

Device Problem Disconnection (1171)

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

Event Date 04/25/2019

Event Type  malfunction  

Manufacturer Narrative

Per -(b)(4) initial report: the appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.The reported devices are available and will be returned to corin for examination.Details of this examination will be provided in a supplemental report upon completion of the investigation.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

Trinity std introducer / impactor handle would not detach from the trinity cup once it had been impacted.The surgeon had to remove the cup, ream and implant a larger size than planned.

Manufacturer Narrative

(b)(4) final report.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.It was found that the trinity handle conformed to material and dimensional specification at the time of manufacture.During the manufacturing process of the trinity cups it was found that a chamfer existed at the base of the thread.This non-conformance was risk assessed and accepted.Additionally this deviation would not have led to the reported event.The devices were reviewed at corin, it was found that the handle and cup could be attached and detached with no issue.However, it was identified that the threaded section of the trinity handle had become damaged.If these threads had been damaged and not identified by the surgeon prior to attaching the cup, it could have led to cross threading and the reported event.Corin are researching a new design for this handle, including a new thread.Based on the above, this case is now considered closed.Please note: this report is filed with the fda due to an adverse 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

Trinity std introducer / impactor handle would not detach from the trinity cup once it had been impacted.The surgeon had to remove the cup, ream and implant a larger size than planned.

• Brand Name: TRINITY
• Type of Device: STD INTRODUCER / IMPATCOR HANDLE
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester; gloucestershire, GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 8639422
• MDR Text Key: 146247156
• Report Number: 9614209-2019-00039
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K093472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• 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: 076086-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRINITY CUP - 321.03.350 - 412540; TRINITY CUP - 321.03.350, 412540