MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; CANCELLOUS SCREW,

Model Number 321.035

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial report.Post operative x-rays, operative notes and a detailed patient outcome has been requested to aid the investigation of this event, 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 have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.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.

Event Description

Trinity cancellous screw snapped during implantation.Part of the screw was left in the patient as it was embeded in the cancellous bone.

Event Description

Trinity cancellous screw snapped during implantation.Part of the screw was left in the patient as it was embeded in the cancellous bone.

Manufacturer Narrative

(b)(4) initial report.The appropriate device details have been 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 of manufacture.Corin has not received any other reports relating to parts from this batch.The surgeon was still able to achieve adequate fixation of the cup and no additional follow-up is required.Based on the information available for this case, no further investigation can be conducted.We will continue to monitor trends relating to this or similar failure modes for the trinity screw and thus now consider this case 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.

• Brand Name: TRINITY
• Type of Device: CANCELLOUS SCREW,
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 7988903
• MDR Text Key: 125454728
• Report Number: 9614209-2018-00079
• 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: 03/27/2020

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 Expiration Date: 08/05/2022
• Device Model Number: 321.035
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 364080
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2018
• Initial Date FDA Received: 10/22/2018
• Supplement Dates Manufacturer Received: 09/27/2018
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1