MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN INTERTAN; INTRAMEDULLARY NAIL & ACCESSORIES

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/01/2015

Event Type  Injury  

Event Description

It was reported that a revision was performed due to broken implants.The surgeon was unable to remove all of the broken pieces, and they still remain inside the patient.

Manufacturer Narrative

No product was returned, hence visual or dimensional inspection could not be completed.No lot number was provided; hence dhr could not be completed.If more information is received, this investigation will be reopened.

• Brand Name: TRIGEN INTERTAN
• Type of Device: INTRAMEDULLARY NAIL & ACCESSORIES
• 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: robert rust ; 1450 brooks road; memphis, TN 38116 ; 9013991624
• MDR Report Key: 4869693
• MDR Text Key: 6059016
• Report Number: 1020279-2015-00413
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention