EXPert Nail 04.003.860SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982083074), received between Jan 15, 2018 and Jan 15, 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.

• InjuryJan 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL WAS PERFORMED DUE TO ATROPHIC NON-UNION OF A RIGHT FEMUR ON (B)(6) 2017. THE ORIGINAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE; IT IS BELIEVED TO BE ABOUT A YEAR AGO. REMOVED HARDWARE INCLUDED: ONE NAIL AND TWO RECON SCREWS -ALL INTACT. THE REMOVAL WAS COMPLETED WITHOUT INCIDENT. THE PATIENT WAS REVISED TO A LARGE FRAGMENT PLATE AND SCREWS. BONE ASPIRATE AUTOGRAFT WAS USED FOR THE NON-UNION. IT IS NOTED THAT THE PATIENT IS ON FOSAMAX. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 15MM LATERAL ENTRY FEMORAL RECON NAIL-EX. (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7189166 ↗

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.