MAUDE Adverse Event Report: SMITH & NEPHEW, INC, TRIGEN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71642225

Device Problems Failure To Adhere Or Bond (1031); Break (1069)

Patient Problem Inflammation (1932)

Event Date 03/29/2016

Event Type  malfunction  

Event Description

Operative report indicates that there was a non-union and osteomyelitis along with the broken screw.

• Brand Name: TRIGEN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC,; 1450 brooks rd; memphis TN 38116
• MDR Report Key: 5580407
• MDR Text Key: 42804323
• Report Number: 5580407
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2016

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: No Information
• Device Catalogue Number: 71642225
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: THERE WERE OTHER UNBROKEN SCREWS AND A PLATE, THAT
• Patient Age: 63 YR
• Patient Weight: 64