EXPert Nail 04.034.658SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982095534), received between Apr 3, 2018 and Apr 3, 2018 — 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.

• InjuryApr 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH A TIBIAL NAIL APPROXIMATELY 5 TO 6 YEARS PRIOR TO REMOVAL. ON UNKNOWN DATE, PATIENT REPORTED PAIN. IT WAS DETERMINED THE NAIL WAS RUBBING AGAINST THE PATELLA. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE THE NAIL AND SCREWS WERE REMOVED FULLY INTACT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT WAS NOT REVISED TO ADDITIONAL HARDWARE AND IS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: LOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 12MM CANNULATED TIBIAL NAIL-EX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7394321 ↗

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.