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

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported that mal-rotation of 30 degrees of the intramedullary nail was identified post-operatively and a corrective revision surgery was performed two days later.

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

• Type of Device: INTRAMEDULLARY NAIL
• 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: 5855349
• MDR Text Key: 51443549
• Report Number: 1020279-2016-00609
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• 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?: Yes
• Date Manufacturer Received: 07/25/2016
• 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