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

Model Number 321.040

Device Problems Break (1069); Material Fragmentation (1261); No Apparent Adverse Event (3189)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial report.It was reported that the broken screw was retrieved and removed and an alternative screw was implanted with no reported issue.The broken screw was discarded following surgery and thus cannot be returned for examination.Additional information, including x-rays and an update on the patient has been requested, 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.

Event Description

Trinity screw went all the way through the cup during surgery and part of the screw head broke off.The broken screw was retrieved and removed and an alternative screw was implanted with no issue.

Manufacturer Narrative

Per -3704 final report it was reported that the broken screw was retrieved and removed and an alternative screw was implanted with no reported issue.The broken screw was discarded following surgery and thus cannot be returned for examination.Post primary x-rays were provided and it was confirmed that the cup was fully seated within the acetabulum prior to the insertion of the screw.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.Additionally, corin has not received any other reports relating to devices from the reported batch of screws.Testing conducted at corin shows that in case screws have been implanted at the correct angle and with an acceptable torque load, screw failures should not happen.Therefore, this event may be the result of disproportionate torque and angulation insertion.No further investigation can be conducted with the available information and thus, this case is now considered closed.Corin will continue to monitor trends relating to this or similar failure modes with the trinity screw.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 screw went all the way through the cup duirng surgery and the screw head stripped.The broken screw was retrieved and removed.An alternative screw was implanted with no complications.

• Brand Name: TRINITY
• Type of Device: CANCELLOUS BONE SCREW
• 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: marie-anne euzen ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 11671762
• MDR Text Key: 251694770
• Report Number: 9614209-2021-00048
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

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: 02/21/2024
• Device Model Number: 321.040
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 414292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TRINITY CUP: 324.03.752, 455885; TRINITY PLUS SHELL: 324.03.752, 445885