MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; FLEXIBLE DEPTH GAUGE

Model Number 921.109

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Measurement System Incompatibility (2982)

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

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported device is being returned and will be reviewed at corin.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.Details of these reviews 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.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 it was identified that the measurement showing on the trinity flexible depth gauge and the length of the measuring tip were different.Surgery was not delayed and there was no patient impact.

Manufacturer Narrative

Per 3886 - final report.The appropriate device details were provided, and the relevant device manufacturing record has been identified and reviewed.This device was supplied in sept 2017 and conformed to material and dimensional specifications at the time of manufacture.The device was returned to corin vigilance, which allowed us to perform a functional testing.It was found that the length of the tip was undersize compared to the reading on the scale by at least 10 mm.Further examination of the faulty gauge proved a mix-up of components between two different suppliers.The sleeve is from the current supplier, whereas the probe matches the drawing from the old supplier.There is a possibility that the components were mixed-up in stc during cleaning and kit-build.A quality alert was accepted by all the goods-in inspectors as a reminder for continued vigilance to carefully the operation, a non-conformity was acknowledged by the supplier which will review the issue with their laser marking team and a capa was raised to determine the root cause and implement the corrective actions associated.Based on this, corin now consider this case 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 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 it was identified that the measurement showing on the trinity flexible depth gauge and the length of the measuring tip were different.Surgery was not delayed and there was no patient impact.

• Brand Name: TRINITY
• Type of Device: FLEXIBLE DEPTH GAUGE
• 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: dardan uka ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 12047683
• MDR Text Key: 263838473
• Report Number: 9614209-2021-00078
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/29/2022

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: 921.109
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 075953-19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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