MAUDE Adverse Event Report: CORIN LTD TRINITY; TRINITY-I MULTI HOLE SHELL Ø46MM TAPER SIZE 2

Model Number 321.02.346

Device Problem Difficult to Remove (1528)

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

Event Date 04/24/2023

Event Type  malfunction  

Manufacturer Narrative

Case (b)(4), initial report: additional information including; the details of the cup, are the devices available for return and if there was any noticeable damage to the instrument/implant before use has been requested and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been requested and if provided 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.

Event Description

During a trinity procedure the impactor handle got stuck in the trinity cup and could not be removed.This extended surgery time under 30 minutes and the surgeon had to remove the impacted cup from the acetabulum and re-ream to implant a larger than planned cup.

Manufacturer Narrative

(b)(4) final report: the appropriate device details were requested and the relevant device manufacturing records have been identified and reviewed.It was found that all parts associated with these records conformed to material and dimensional specifications, and no non-conformities or deviations from processes were recorded that could have caused or contributed to the reported event.The devices were shipped to corin uk on 09-jun-23, however as of 12-dec-23 they have not been received by corin uk.As the devices have not been returned, the failure mode cannot be confirmed, and the root cause is not determined.Based on the information available, no further investigation can be conducted at this time, and the root cause is unknown.The 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-I MULTI HOLE SHELL Ø46MM TAPER SIZE 2
• 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: 16866606
• MDR Text Key: 314537651
• Report Number: 9614209-2023-00186
• Device Sequence Number: 1
• Product Code: LZO
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

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: 321.02.346
• Device Lot Number: 514331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/28/2023
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NON-CORIN HANDLE 3991055, 193305A; NON-CORIN HANDLE 399105500, 201059A2,; NON-CORIN HANDLE 3991055003, 201059
• Patient Outcome(s): Required Intervention