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

Model Number 921.129

Device Problem Loose or Intermittent Connection (1371)

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

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 and details following the review 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 screw in the black plastic section of a trinity std introducer / impactor handle became loose which resulted in the trinity cup being unable to be unscrewed from the handle.A second handle was used and surgery was completed successfully with no impact to the patient.

Manufacturer Narrative

Per -(b)(4) final report.No adverse event has been reported.The appropriate device details were provided and the relevant device manufacturing records were identified and reviewed.This device conformed to material and dimensional specification at the time of manufacture.The failure mode of this device has been reported to corin previously and as a result of feedback from the field a project has been initiated to implement a new design for this device.Based on this, corin now consider 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 screw in the black plastic section of a trinity std introducer / impactor handle became loose which resulted in the trinity cup being unable to be unscrewed from the handle.A second handle was used and surgery was completed successfully with no impact to the patient.

• Brand Name: TRINITY
• Type of Device: TRINITY 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: 6141059
• MDR Text Key: 61599469
• Report Number: 9614209-2016-00157
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 921.129
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 059815-16
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2012
• 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