MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 18CM 130D; INTRAMEDULLARY NAIL AND ACCESSORIES

Catalog Number 71675207

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 10/14/2013

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to pain.

Manufacturer Narrative

Manufacturer Narrative

The associated complaint device was not returned.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: INTERTAN 10MM X 18CM 130D
• Type of Device: INTRAMEDULLARY NAIL AND 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: lisa hassell ; 1450 brooks road; memphis, TN 38116 ; 9013991128
• MDR Report Key: 4343634
• MDR Text Key: 5177316
• Report Number: 1020279-2014-00757
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Type of Report: Initial
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71675207
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2014
• 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