EXPert Nail 04.003.257SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982081865), received between Dec 26, 2017 and Dec 26, 2017 — 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.

• InjuryDec 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS TREATED WITH A 9 MM X 380 MM SYNTHES LATERAL ENTRY FEMORAL NAIL (LEFN) FOR A FEMUR FRACTURE ON AN UNKNOWN DATE IN (B)(6) 2015. ON A SUBSEQUENT UNKNOWN DATE, THE SURGEON DETERMINED THAT THE PATIENT HAD A DELAYED NON-UNION OF THE FEMUR. ON (B)(6) 2017, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR HARDWARE REMOVAL AND REVISION TO A LONGER 11 MM X 380 MM LEFN NAIL. THERE WAS NO REPORTED SURGICAL DELAY, NO BROKEN HARDWARE OR FRAGMENTS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7145661 ↗

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.