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

Model Number NOT PROVIDED

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

Per (b)(4) initial report.Device details and return of the reported devices has been requested in order to progress with the investigation of this event, and if received, will be reviewed at corin.Details of this review 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.

Event Description

Trinity cup became stuck on the trinity std introducer / impactor handle during surgery.The cup was removed and the surgeon then re-reamed and implanted a larger size cup with a new handle.

Manufacturer Narrative

Per 2762 - final report.The cup and the handle were not returned for examination, therefore the investigation was limited.The appropriate device details (part number and lot code) were not provided, and consequently the relevant device manufacturing records have not been identified and reviewed.Furthermore, the reported device was unable to be returned and the failure mode could not be confirmed.No further investigation for this event is possible as no devices and insufficient information was received by corin.Therefore, corin now considers this case closed.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 occured 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 cup became stuck on the trinity std introducer / impactor handle during surgery.The cup was removed and the surgeon then re-reamed and implanted a larger size cup with a new handle.

• Brand Name: TRINITY
• Type of Device: STD INTRODUCER / IMPACTOR HANDLE
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 9737908
• MDR Text Key: 190903596
• Report Number: 9614209-2020-00018
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K093472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

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: NOT PROVIDED
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRINITY CUP - DEVICE DETAILS NOT PROVIDED; TRINITY CUP - DEVICE DETAILS NOT PROVIDED