MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; MODULAR HEAD TRIAL

Model Number E922.336

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Insufficient Information (3190); Device Fell (4014)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 08/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial report.Additional information, including a confirmation that the broken part of the device is available for return, if the device broke, if the device fell by accident due to incorrect handling, if the surgeon did anything unusual during the procedure 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 not been provided yet, therefore manufacturing records are yet to be located.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

During surgery the trinity trial head fell off the broach neck and into the hip cavity.The surgeon could not locate the trial head by hand and was concerned about pushing it up further so decided to close the patient up and do an mri to locate the instrument and then surgically remove it later.This caused a 60 minute surgical delay.

Manufacturer Narrative

Per -4938 final report additional information including the return of both devices, photographs of the neck trials, device lot code & part number and an update on the patient post revision was requested.This information could not be provided and only the head trial was returned.The appropriate device details were provided for the head trial and the relevant device manufacturing and sterilisation records have been identified and reviewed.All parts associated with these records were cleaned, packaged and sterilised to the correct specifications at the time of manufacture.Testing on the head trial was unable to confirm or replicate the failure mode using the available neck trials in stock.Based on the available information, no further investigation can be conducted.The root cause of the incident is unknown as the neck trial has not been returned and no more information is available.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

During surgery the trinity trial head fell off the broach neck and into the hip cavity.The surgeon could not locate the trial head by hand and was concerned about pushing it up further so decided to close the patient up and do an mri to locate the instrument and then surgically remove it later.This caused a 60 minute surgical delay.

• Brand Name: TRINITY
• Type of Device: MODULAR HEAD TRIAL
• 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: dardan uka ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 15197696
• MDR Text Key: 298810383
• Report Number: 9614209-2022-00070
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: E922.336
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 223892-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 08/03/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TRIFIT TS NECK TRIAL - LOT & PART NO. NOT PROVIDED
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male