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

Model Number 921.129G

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Per (b)(4) initial report.The device details for the associated trinity cup have been requested, along with return of both devices, and if received, they will be reviewed at corin.Details of this review shall be provided in a supplemental report upon completion of the investigation.Upon receipt of the 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

During surgery the definitive implant could not be unscrewed from the handle and thus had to be removed.A second trinity cup and trinity handle were used.

Event Description

During surgery the definitive implant could not be unscrewed from the handle and thus had to be removed.A second trinity cup and trinity handle were used.

Manufacturer Narrative

(b)(4) - final report the shell was not returned for examination, therefore the investigation was limited.The appropriate device details were provided and the relevant device manufacturing record has been identified and reviewed.All finished parts associated with this record conformed to material and dimensional specifications at the time of manufacture.The trinity std introducer handle was returned and the functional parts of the device are intact with no damage.Assessment of the returned instrument found the device to be functionally acceptable.Therefore, corin now considers 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.

• Brand Name: TRINITY
• Type of Device: STD INTRODUCER / IMPACTOR HANDLE,
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester; cirencester, gloucestershire GL71Y J; UK GL71YJ
• MDR Report Key: 9737913
• MDR Text Key: 190903697
• Report Number: 9614209-2020-00019
• 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: 06/28/2021

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: 218810-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRINITY CUP - DEVICE DETAILS UNKNOWN; TRINITY CUP - DEVICE DETAILS UNKNOWN