EXPert Nail 04.004.255SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982083692), received between Aug 5, 2022 and Aug 5, 2022 — 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.

• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022,THAT A TIBIA NAIL WAS BEING REMOVED FROM A PATIENT DUE TO A NON UNION. THE DR. DOING THE REVISION THOUGHT THAT THE ORIGINAL IMPLANT WAS NOT A SUFFICIENT DIAMETER TO PROVIDE PROPER SUPPORT AND WANTED TO REMOVE THE CURRENT IMPLANT (8X375 TIBIA NAIL EX) AND REPLACE IT WITH A LARGER DIAMETER (10X375 TIBIA NAIL ADVANCED). THE NAIL AND 4 LOCKING SCREWS WERE SUCCESSFULLY REMOVED AND REPLACED. THE LOCKING SCREWS THAT WERE REMOVED WERE 5.0 DUAL CORE SCREWS X 2 AND 4.0MM LOCKING SCREW X2. THERE WAS PATIENT OUTCOME/CONSEQUENCES- NONUNION. CONCOMITANT DEVICE: UNKNOWN LOCKING/SET SCREWS (PRODUCT CODE: UNK, LOT NUMBER: UNK, QUANTITY: 4) THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 8 TI CANNULATED TIBIAL NAIL-EX/375-SILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15173866 ↗

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.