EXPert Nail 04.003.561SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982082480), received between Apr 21, 2021 and Apr 21, 2021 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K040336); 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.

• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A HARDWARE REMOVAL OF ADULT LATERAL ENTRY FEMORAL NAIL (ALEFN) DUE TO PATIENT COMPLAINING OF PAIN. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) 12MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/LT-STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11700341 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040336. One submission often covers many models, so check the product and lot details in each record.

• Z-1915-2015 · May 27, 2015 · Terminated
  DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Sub
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.