MAUDE Adverse Event Report: CORIN LTD TRINITY; TRINITY LINER IMPACTOR HEAD

Model Number 921.036

Device Problem Fracture (1260)

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

Event Date 09/13/2023

Event Type  malfunction  

Event Description

During surgery, whilst impacting the trinity ecima liner, the liner impactor head broke.Broken parts of the liner impactor head were retrieved from the joint space and there was no reported patient impact or delay to surgery.

Manufacturer Narrative

Case (b)(4), initial report.Additional information including; was the impactor aligned correctly before impaction, was a crack notices on the impactor prior to impaction and how is the patient doing post operation has been requested and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided and 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.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.

Manufacturer Narrative

(b)(4) final report.Additional information including; whether the impactor was aligned correctly before impaction, were any cracks noticed on the impactor head prior to impaction and an update on the patient post-op was requested in order to aid the investigation.The reporter confirmed that the impactor head was aligned and screwed on correctly and that the crack was identified after use.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.It was found that this device was manufactured in jun 2022 as part of a batch of 28 and conformed to material and dimensional specification at the time of manufacture.The device was not returned to corin uk, however, a photograph was provided which confirmed the reported failure.This failure has been reported to corin previously and corrective actions are currently being implemented to improve the durability of the device.Therefore, this case is now considered 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 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.

• Brand Name: TRINITY
• Type of Device: TRINITY LINER IMPACTOR HEAD
• Manufacturer (Section D): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD; 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: 17866441
• MDR Text Key: 324880938
• Report Number: 9614209-2023-00248
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 921.036
• Device Lot Number: 088122-201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Distributor Facility Aware Date: 09/13/2023
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2022
• 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