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

Model Number 921.129G

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No ae reported.The appropriate device details have been provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification.The reported device is being returned to corin for examination, following the review, details will be provided in a supplemental report upon completion of the investigation.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 trinity cup could not be removed from a trinity std introducer / impactor handle.Surgery was completed successfully with no impact to the patient.

Manufacturer Narrative

Per -77 final report.No adverse event reported.It has been confirmed that surgery was completed successfully with no impact to the patient.The appropriate device details were provided and the relevant device manufacturing records were identified and reviewed.All parts associated with these records conformed to material and dimensional specification.Upon receipt of the device at corin it was confirmed that the cup had become stuck on the handle.The possible root causes of this failure mode were discussed and it was concluded that the thread on the handle may have become damaged prior to attachment of the cup which may have led to cross threading.As a result of feedback from the field, corin have initiated a project to research a new design for this instrument, including a new thread.Based on this, corin 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 trinity cup could not be removed from a trinity std introducer/impactor handle.Surgery was completed successfully with no impact to the patient.

• 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: 6141064
• MDR Text Key: 61598750
• Report Number: 9614209-2016-00158
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

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: 921.129G
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 336891-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• 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