MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META NAIL IMPLANT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Injury (2348)

Event Date 03/03/2020

Event Type  Injury  

Event Description

It was reported that the patient has sn components for almost 1.5 years ago and there was an infection.It is unknown when the revision surgery was performed.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A risk management review and instructions for use are typically looked at but could not be performed due to the lack of product and information for the product.Our clinical/medical team noted: without the requested clinical information a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-evaluated.We could not review the sterilization files.A root cause could not be determined at this time with the information provided.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: META NAIL IMPLANT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9812650
• MDR Text Key: 182764546
• Report Number: 1020279-2020-00824
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/10/2020
• Supplement Dates Manufacturer Received: 11/16/2020
• Supplement Dates FDA Received: 11/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention