EXPert Nail 04.003.664SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982082695), received between May 15, 2019 and May 15, 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.

• InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF TITANIUM LATERAL ENTRY FEMORAL RECON NAIL DUE TO PAIN. IT HAD NO DISTAL INTERLOCKING SCREWS. THE LATERAL ENTRY NAIL WAS REMOVED SUCCESSFULLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) LATERAL ENTRY FEMORAL RECON NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8611648 ↗

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.