EXPert Nail 04.004.355SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982083975), received between Oct 1, 2018 and Jan 14, 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.

• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 1 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11171656 ↗
• InjuryOct 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT IMPLANT PROCEDURE IN MEXICO. POST-OPERATIVE, ON (B)(6) 2018, PATIENT UNDERWENT HARDWARE REMOVAL DUE TO INFECTION AND NON-UNION. DURING THE REMOVAL, THE TITANIUM (TI) CANNULATED TIBIAL NAIL-EX, TI END CAP AND TWO (2) PROXIMAL SCREWS WERE REMOVED. THE TIBIA WAS REAMED, AND THEN TISSUE SPECIMENS WERE COLLECTED AND SENT TO THE LABORATORY. ANTIBIOTIC BEADS WERE APPLIED AS A TREATMENT FOR THE INFECTION. PATIENT OUTCOME WAS UNKNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 9MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

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

  MAUDE report 7922586 ↗

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.