NA 04.015.540Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982088925), received between Mar 11, 2019 and Mar 11, 2019 — 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 16, 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 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  04/16/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF INTRAMEDULLARY NAIL (IM NAIL) WITH EXCHANGE NAILING OF THE RIGHT TIBIA DUE TO NON-UNION. ALL HARDWARE WAS REMOVED COMPLETELY. NONE OF THE HARDWARE WAS BROKEN. THE MEDULLARY CANAL WAS PREPPED FOR A LARGER TIBIAL NAIL. A 10X360 MM TIBIAL NAIL WAS IMPLANTED AND LOCKED DISMALLY AND PROXIMAL. ORIGINAL IMPLANT DATE WAS ON (B)(6)2015. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT WAS STABLE UPON COMPLETION OF THE PROCEDURE. THIS COMPLAINT INVOLVES NINE (9) DEVICES.

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

  MAUDE report 8410257 ↗

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.