MAUDE Adverse Event Report: CORIN LTD (UK & FR) TRINITY; STD INTRODUCER/IMPACTOR HANDLE

Model Number 921.129

Device Problem Failure to Disconnect (2541)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/07/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information including; operative notes, an update on the patient, was all the debris taken out of the patient, post op x-rays & photos of the device 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.

Event Description

During surgery a trinity std introducer/impactor handle disengaged from the handle and became stuck in the cup in situ.Whilst struggling to remove the handle, debris fell in the operative wound.

• Brand Name: TRINITY
• Type of Device: STD INTRODUCER/IMPACTOR HANDLE
• Manufacturer (Section D): CORIN LTD (UK & FR); the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD (UK & FR); 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: 16435236
• MDR Text Key: 310140247
• Report Number: 9614209-2023-00163
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2023

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: 921.129
• Device Lot Number: 085860-04
• Distributor Facility Aware Date: 02/07/2023
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention