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

Model Number 921.129G

Device Problem Break (1069)

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

Event Date 08/31/2023

Event Type  malfunction  

Event Description

During surgery, the trinity handle was impacted and subsequently, the thread of the introducer handle broke off inside the patient.This was retrieved and there was no delay in surgery and no reported patient impact.

Manufacturer Narrative

(b)(4).Initial report additional information, including could the thread have been damaged prior to impaction of the liner (when impacting the trial cup or definitive acetabular cup), was the trinity handle threaded into the liner impactor head when impacting the liner, was the handle was screwed into the liner impactor head whilst impacting the liner, this failure should only have been identified when removing the liner impactor head from the handle once the liner was engaged - is this what happened and was there any damage to the liner impactor head has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details has been requested and once 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.

• Brand Name: TRINITY
• Type of Device: TRINITY STD INTRODUCER / IMPACTOR HANDLE
• 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 uks ; the corinium centre; cirencester; gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 17841704
• MDR Text Key: 324552482
• Report Number: 9614209-2023-00244
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 921.129G
• Device Lot Number: 074676-10
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/01/2023
• Distributor Facility Aware Date: 08/31/2023
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2017
• 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
• Treatment: TRINITY CUP 321.04.356, 532319
• Patient Outcome(s): Other