MAUDE Adverse Event Report: SMITH AND NEPHEW ANTEGRADE NAIL; NAIL, FIXATION, BONE

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2020, the patient underwent removal of a broken va-lcp condylar plate and a smith and nephew antegrade nail.It will be revised to smith a nephew antegrade nail and a ohs plate.No fragments were generated during removal.The procedure was successfully completed.Patient status was unknown.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ANTEGRADE NAIL
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 17525865
• MDR Text Key: 321043684
• Report Number: MW5132806
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1