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

Model Number 321.025

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

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

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

Per -(b)(4) initial report.Additional information and return of the metal fragment has been requested in order to progress with the investigation of this event, and if received, will be reviewed at corin and details will be provided in a supplemental report upon completion of the investigation.The reported trinity screw was implanted and thus cannot be returned for examination.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.

Event Description

A piece of metal was found intra-operatively following implantation of a trinity screw.The metal piece was retrieved and the screw has remained in situ.

Event Description

A piece of metal was found intra-operatively following implantation of a trinity screw.The metal piece was retrieved and the screw has remained in situ.

Manufacturer Narrative

Per -3818 initial report: additional information, including x-rays, operative notes, an update on the patient, how many screws were implanted, surgeon experience with trinity, surgical approach used, implantation angulation and device detail of the screwdriver used has been requested in order to progress with the investigation of this event.Except for the angulation, which was reported to be appropriate, this information could not be provided.The reported trinity screw was implanted and thus cannot be returned for examination.However, the fragment found was returned and reviewed and it was confirmed it came from the head of the screw.The appropriate device details were provided, and the relevant device manufacturing records have been identified and reviewed.Review of these records revealed no deviation from process or non-conformity of product that would have caused or contributed to the adverse event.Testing shows that in case screws have been implanted at the correct angle and with an acceptable torque load, screw failures should not happen.Therefore, the metal fragment found during the surgery could have been a result of disproportionate torque and angulation insertion.No further investigation can be conducted.Therefore, this case is now considered closed, however, should any additional information be provided which requires further investigation then this case may be re-opened.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 ACETABULAR HIP SYSTEM
• Type of Device: CANCELLOUS BONE SCREW
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: marie-anne euzen ; the corinium center; cirencester, GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 11892424
• MDR Text Key: 255965628
• Report Number: 9614209-2021-00069
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/14/2022

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 Model Number: 321.025
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 462050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• 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 CLUSTER SHELL: PART 321.03.352 LOT 452270