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

Model Number 921.129

Device Problems Loose or Intermittent Connection (1371); No Apparent Adverse Event (3189)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Per (b)(4) initial report.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.The instrument is being returned and will also be reviewed.Details of these reviews will be provided in a supplemental report upon completion of the investigation.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.

Event Description

Trinity std introducer / impactor handle came loose during surgery when hit with a mallet.

Manufacturer Narrative

Per -3284 final report the appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time ot manufacture.The cup was implanted, however, the trinity handle was returned and reviewed.Damage was observed to the thread.It has been concluded that the root cause of this event was wear and tear to the threaded section of the handle, 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 an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

Event Description

Trinity std introducer / impactor handle came loose from the cup during surgery when hit with a mallet.

• Brand Name: TRINITY
• Type of Device: STD INTRODUCER / IMPACTOR HANDLE
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 10893899
• MDR Text Key: 230999052
• Report Number: 9614209-2020-00110
• 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: 06/11/2021

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: 921.129
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 292579-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRINITY CUP - 321.05.364, 355816