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

Model Number 921.129G

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 08/26/2022

Event Type  malfunction  

Manufacturer Narrative

Per (b)(4) initial report, additional information including the device operative notes, whether the cup was fully threaded prior to impaction, whether there was any thread damage prior to use, an update on the patient post-op and whether the devices are available for examination has been requested in order to progress with the investigation of this event, and if receieved, will be provided in a supplemental report upon completion of the investigation.Upon receipt of the appropriate device details, the relevant device manufacturing records will be identified and reviewed.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

Trinity liner impactor handle became stuck in trinity cluster shell due to loosing of the handle.A different size cluster shell was then used.This event caused a surgical delay 20 mins.

Manufacturer Narrative

Per -5022 final report.Additional information, including operative notes, whether the cup was fully threaded onto the handle prior to impaction, whether there was any thread damage prior to use and an update on the patient post-surgery was requested.No response to these requests were received.The appropriate device details have been provided and the relevant device manufacturing records have been identified and reviewed.It was found that all finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.This failure mode has been reported to corin previously and a new design for the trinity handle is currently being researched.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 that the device reporting entity, entity's representative or distributor caused or contributed to this event.

Event Description

Trinity std introducer / impactor handle became stuck in trinity cluster shell due to loosing of the handle.A different size cluster shell was then used.This event caused a surgical delay 20 mins.

• Brand Name: TRINITY
• Type of Device: TRINITY STD INTRODUCER / IMPACTOR HANDLE
• 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; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 15326597
• MDR Text Key: 305492082
• Report Number: 9614209-2022-00087
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 921.129G
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 085860-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 08/26/2022
• Supplement Dates FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2020
• 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 CLUSTER SHELL 321.04.35, 496872; TRINITY CLUSTER SHELL SIZE: 321.04.35, 496872