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

Model Number 921.129

Device Problems Mechanical Problem (1384); Difficult to Remove (1528)

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

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

Per(b)(4) initial report.The appropriate device details of the reported trinity cup have been provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.The device details of the reported handle have not yet been provided, however, they have been requested and upon receipt the relevant device manufacturing records will be identified and reviewed.It is unknown at this time whether the reported devices can be returned to corin for examination.If they are, details of this review shall 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

During surgery the trinity handle could not be detached from the cup following impaction.The cup was then removed and a new cup implanted with no reported issues.Surgery was delayed by approximately 20 minutes.

Manufacturer Narrative

Per 3171 - 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 specifications atht the time of manufacture.2 trinity handles were returned.Unfortunately, the cluster shell was unreturned.The failure mode has been reported to corin previously ans as a result of the feedback from the field, capas were raised for the damage to distal thread.Consequently, a new design was released.Based on this, corin now considers this case closed.Please note: this report is filled with the fda due to an adverse event epxerienced with a device that is similar to those placed on the market in the usa, however, this event occured 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

During surgery the trinity handle could not be detached from the cup following impaction.The cup was then removed and a new cup implanted with no reported issues.Surgery was delayed by approximatively 20 mintues.

• 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
• MDR Report Key: 10654434
• MDR Text Key: 230999427
• Report Number: 9614209-2020-00084
• Device Sequence Number: 1
• Product Code: LWJ
• 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: 07/19/2021

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: 921.129
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 246255 & 075599
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 09/14/2020
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRINITY CUP - 321.04.358 LOT 450517; TRINITY CUP - 321.04.358, 450517