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

Model Number 921.129

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

Per -145 initial report no adverse event reported.The appropriate device details have been provided and the relevant device manufacturing record will be retrieved and reviewed and details will be provided in a supplemental report upon completion of this investigation.The reported failure mode in this case has been reported to corin previously and 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 consider this case closed.

Event Description

The thread of a trinity std introducer / impactor handle is damaged.

Manufacturer Narrative

Per -145 final report.No adverse event reported.The appropriate device details were provided and the relevant device manufacturing records were identified and reviewed, it was found that this device conformed to material and dimensional specification at the time of manufacture.The reported failure mode in this case has been reported to corin previously and 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 consider this case closed.

Event Description

The thread of a trinity std introducer / impactor handle is damaged.

• 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: 6193007
• MDR Text Key: 63234706
• Report Number: 9614209-2016-00162
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/08/2017

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: 921.129
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 286693-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2014
• 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