EXPert Nail 04.013.540SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982088017), received between Feb 20, 2019 and Feb 20, 2019 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K033618); 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.

• InjuryFeb 20, 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 CANNULATED FEMORAL NAIL AND THREE 5.0MM SCREWS DUE TO INFECTION-NON-UNION. ANTIBIOTICS WERE APPLIED DURING IN THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 11MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/300MM-STERILE. THIS REPORT IS 1 OF 2 FOR (B)(4).

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

  MAUDE report 8356506 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033618. One submission often covers many models, so check the product and lot details in each record.

• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.