EXPert Nail 04.004.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982083494), received between Feb 15, 2019 and May 31, 2021 — classified as 2 injuries.

2 other recalls cover devices cleared under the same FDA submission (K040762); 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 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A TIBIA NAIL HARDWARE REMOVAL DUE TO NON-UNION WITH EXCHANGE NAILING REMOVAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) TI END CAP FOR TIBIAL NAILS-EX T40 STARDRIVE GRAY/10MM EXT. THIS IS REPORT 7 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11909303 ↗
• InjuryFeb 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  03/21/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON AN (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL OF A TITANIUM (TI) CANNULATED TIBIAL NAIL, TWO (2) SCREWS AND A TITANIUM END CAP DUE TO AN INFECTED NONUNION. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. ANTIBIOTICS APPLIED TO PATIENT IN REVISION SURGERY.

  Patient problems: Impaired Healing; No Code Available; Unspecified Infection

  MAUDE report 8343837 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040762. One submission often covers many models, so check the product and lot details in each record.

• Z-2051-2015 · Jun 3, 2015 · Terminated
  TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.