EXPert Nail 04.003.353SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982082046), received between Apr 11, 2018 and Apr 11, 2018 — 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 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FEMORAL NAIL REMOVAL ON (B)(6) 2018 DUE TO PAINFUL HARDWARE. ONE 10MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/360MM/LT-STERILE AND FOUR 5.0MM TITANIUM LOCKING SCREWS IMPLANTED ON AN UNKNOWN DATE (ALMOST A YEAR AGO) WERE REMOVED INTACT. NOTHING WAS IMPLANTED AFTER THE REMOVAL OF HARDWARE. THE PROCEDURE WAS COMPLETED WITHOUT ANY DELAY AND THE PATIENT WAS STABLE AFTER THE SURGERY. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7422897 ↗

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.