EXPert Nail 04.003.348SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982082015), received between Jan 3, 2019 and Jan 3, 2019 — 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 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT HAD UNDERGONE REMOVAL OF HARDWARE AND REVISION SURGERY DUE TO NONUNION AND DELAYED HEALING. ORIGINAL DATE OF IMPLANT PROCEDURE WAS DONE ON (B)(6) 2018 AT AN OUTSIDE FACILITY FOR A SEGMENTAL FEMUR FRACTURE. THE SURGEON AT THAT TIME USED AN UNKNOWN LATERAL ENTRY FEMORAL NAIL (LEFN) AND A VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE TO TREAT THE FRACTURE. ALL DEVICES WERE REMOVED SUCCESSFULLY. A RETROGRADE NAIL WAS INSERTED FOR THE REVISION PROCEDURE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED AND PATIENT OUTCOME IS GOOD. THIS COMPLAINT INVOLVES SIX (6) DEVICES . THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT . THIS REPORT IS 2 OF 6 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8215188 ↗

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.