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

Model Number 921.129G

Device Problems Entrapment of Device (1212); Mechanical Problem (1384)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

Per (b)(4).Device details and the return of the reported devices has been requested in order to progress with the investigation of this event, and if received, the devices will be reviewed at corin and details of this review will be provided in a supplemental report upon completion of the investigation.Upon receipt of the appropriate device details the relevant device manufacturing records will be identified and reviewed.Please note: this report is filed with the fda due to an adverse 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 cup became stuck on the trinity std introducer / impactor handle during surgery.The cup was then removed and a competitor product was implanted.

Manufacturer Narrative

(b)(4) - initial 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 at the time of manufacture.The trinity handle and the cup were returned and reviewed.This failure mode has been reported to corin previously and 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 consider this case closed.Please note: this report is filed with the fda due to an adverse event experienced 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

Trinity cup became stuck on the trinity std introducer / impactor handle during surgery.The cup was them removed and a competitor product was implanted.

• Brand Name: TRINITY
• Type of Device: STD INTRODUCER / IMPACTOR HANDLE
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 9737900
• MDR Text Key: 190901211
• Report Number: 9614209-2020-00017
• 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: 07/09/2021

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: 921.129G
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 080539-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRINITY CUP - 321.02.348 LOT 437642; TRINITY CUP - 321.02.348, 437642