EXPert Nail 04.034.555SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982095398), received between Jun 5, 2018 and May 18, 2020 — 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 16, 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 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF TIBIAL NAIL DUE TO INFECTED TIBIA AND WAS REPLACED WITH A NEW NAIL. THE PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 10064990 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH THE 11MM CANNULATED TIBIAL NAIL-EX AND SIX (6) 5.0MM LOCKING SCREWS ON (B)(6) 2017. ON UNKNOWN DATE, PATIENT PRESENTED WITH A FLASHED OPEN TIBIAL-FIBULAR FRACTURE FROM A MOTOR VEHICLE ACCIDENT, AS WELL AS AN INFECTION AND NON-UNION. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 11MM CANNULATED TIBIAL NAIL-EX THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7571636 ↗

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.