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

Model Number 321.100

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No ae reported.Additional information, including device details and the return of the reported device has been requested in order to progress with this investigation, and if received, will be provided in a supplemental report upon completion of the investigation.The relevant device manufacturing records will be retrieved and reviewed upon receipt of the appropriate device details.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

The surgeon impacted a trinity cup but was unable to insert the central screw.

Manufacturer Narrative

(b)(4) final report.No ae reported.Additional information, including device details and the return of the reported device to (b)(4) was requested in order to progress with this investigation, however, only limited information was received.The relevant device manufacturing records could not be identified or reviewed as the appropriate device details were not provided.The trinity cup was implanted, however, the associated occluder was returned to (b)(4) for examination.It was found, upon inspection of the occluder at (b)(4), that there was an undercut present on the device which would have prevented full insertion of the occluder into the shell.There are two approved manufacturing routes for this device: in-house and sub-contract.Without batch details we are unable to establish through which route this particular device was manufactured.The in-house manufacturing process has been reviewed and corrective actions have been identified to prevent re-occurrence of the failure mode.Additionally, the sub-contract manufacturer has implemented 100% inspection of the critical features, including the thread detail.This is the only report, to date, that corin has received for this issue.Corin will continue to monitor trends for this failure mode, but now considers this case 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.

Event Description

The surgeon impacted a trinity cup but was unable to insert the central screw.

• Brand Name: TRINITY
• Type of Device: ACETABULAR HIP SYSTEM
• 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: lucinda gerber ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 1285659866
• MDR Report Key: 5853708
• MDR Text Key: 51924066
• Report Number: 9614209-2016-00106
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/27/2017

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 Model Number: 321.100
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 08/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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