MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN; INSTRUMENT

Catalog Number 71654526

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 12/29/2014

Event Type  Injury  

Event Description

It was reported that surgery was delayed due to the surgeon having difficulty implanting the device.

Manufacturer Narrative

• Brand Name: TRIGEN
• Type of Device: INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: melanie travis ; 1450 brooks road; memphis, TN 38116 ; 9013996233
• MDR Report Key: 4418062
• MDR Text Key: 5374407
• Report Number: 1020279-2015-00022
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71654526
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR