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

Model Number 921.129G

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 04/21/2017

Event Type  malfunction  

Manufacturer Narrative

Per -326 initial report.This initial report is being submitted now as it was erroneously submitted as a follow-up report in error.No adverse event reported.The malfunction of this device was identified in the healthcare facility sterile services department and thus no patient was involved.The appropriate device details have been provided and the relevant device manufacturing records have been identified and reviewed.This device conformed to material and dimensional specification.Corin have previously been made aware of this failure mode with this device and thus a project has been initiated to research a new design for this instrument, including a new thread.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 thread on a trinity std introducer impactor handle is broken.The broken thread was identified in the healthcare facility and thus no patient was involved.

• 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
• MDR Report Key: 6593941
• MDR Text Key: 206959909
• Report Number: 9614209-2017-00030
• 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
• Report Date: 05/26/2017

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: 318620-03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2015
• 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