EXPert Nail 04.013.476SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982087935), received between Jul 26, 2022 and Jul 26, 2022 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K033618); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON USED A RETROGRADE FEMORAL NAIL TO SPAN A KNEE SPACER AFTER REMOVING A TOTAL KNEE PROSTHESIS. THIS IS A COMMON PRACTICE FOR THE SURGEON TO DO FOR KNEE SPACERS. THE SPACER WILL THEN BE REMOVED BY MEANS OF CUTTING THE NAIL IN HALF AND EXTRACTING AT THE TIME THAT THE SURGEON PLANS TO COMPLETE THE KNEE REVISION. THERE ARE NO COMPLAINTS OR ADVERSE EVENTS RELATED TO SYNTHES PRODUCTS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 10MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/480MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15106141 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033618. One submission often covers many models, so check the product and lot details in each record.

• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.