EXPert Nail 04.003.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982081292), received between Jan 22, 2021 and May 2, 2025 — classified as 2 injuries.

2 other recalls cover devices cleared under the same FDA submission (K033618, K040336, K172157); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT HARDWARE REMOVAL OF NAIL, FOUR SCREWS, AND END CAP. IT WAS A STAGE 2 PROCEDURE FOR NON-UNION. NO FRAGMENTS WERE RETAINED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21952817 ↗
• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF TITANIUM CANNULATED LATERAL ENTRY FEMORAL RECON NAIL, TITANIUM END CAP AND UNKNOWN LOCKING SCREW DUE TO UNKNOWN REASON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) TI END CAP T40 STARDRIVE 0MM EXT FOR FEMORAL NAILS-EX. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11214626 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033618, K040336, K172157. 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.