EXPert Nail 04.004.755SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982085085), received between Mar 3, 2023 and Mar 3, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM NETHERLANDS REPORTS AN EVENT AS FOLLOWS: THE SITE ROE (ROTTERDAM, NETHERLANDS) REPORTED AN ADVERSE EVENT IN OUR DATABASE WHICH IS CONSIDERED (POSSIBLY) RELATED TO THE DEVICE. SUBJECT ROE-018 POSTOPERATIVE ADVERSE EVENT: "OTHER AE RELATED TO THE PROCEDURE OR IMPLANT: PERSISTING PAIN OF IMPLANT" IS THE AE RELATED TO THE TIBIAL FRACTURE AND/OR TREATMENT OF TIBIAL FRACTURE? "YES" IS THE AE RELATED TO THE DEVICE? "YES" DPS IMPLANT WAS USED. THIS REPORT IS FOR A 13MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 16479004 ↗

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.