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

Model Number 321.030

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

During surgery the surgeon believed that the screw had gone all the way through the cup so he explanted it and tried to re-implant but the same issue occurred.A piece of the screw head then also came off.The surgeon explanted the cup and implanted the next size up without the use of screws.

Manufacturer Narrative

Per (b)(4) initial report.Additional information, including angulation of the screw during insertion, what instruments were used to prepare the bone, whether the cup was fully impacted in the acetabulum prior to the insertion of any screws and whether the devices are available to return for examination, has been requested in order to progress with 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 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.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 the surgeon believed that the screw had gone all the way through the cup so he explanted it and tried to reimplant but the same issue occurred.A piece of the screw head then also came off.The surgeon explanted the cup and implanted the next size up without the use of screws.

Manufacturer Narrative

Per -4260 final report.The appropriate device details were provided and the manufacturing records were identified and reviewed.It was found that the parts were manufactured on 04 jan 2018 and 06 jul 2021 and finished parts conformed to material and dimensional specifications at the time of manufacture.The reporter provided the following information: corin instruments were used to prepare the screw hole, the drill bit size was medium, the surgeon is experienced and no indication to suggest the screw was put in any other way than in accordance with operative techniques.The failure was confirmed on the returned part.This failure has already been investigated in the past and it was concluded that the most probable root cause for the metal fragment being detached from the screw head could have been incorrect torque and angulation based on this, this file is now considered as 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 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 BONE SCREW
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, GL7 1 YJ,; UK GL7 1YJ,
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gl7 1yj GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester, GL7 1-YJ, ; UK GL7 1YJ,
• MDR Report Key: 12785946
• MDR Text Key: 281505166
• Report Number: 9614209-2021-00135
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/29/2022

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: 01/01/2023
• Device Model Number: 321.030
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 377098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2018
• 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: 321.04.354, 474867; TRINITY CUP: 321.04.354, 474867