EXPert Nail 04.034.455SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982095268), received between Nov 9, 2020 and Jul 21, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE PATIENT UNDERWENT THE REMOVAL OF IMPLANTS DUE TO AN INFECTED NONUNION OF THE RIGHT TIBIA. ALL DEVICES WERE REMOVED SUCCESSFULLY. THERE WERE NO BROKEN IMPLANTS. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ORIGINAL DATE OF IMPLANT WAS (B)(6) 2020. THIS REPORT IS FOR ONE (1) 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 12204806 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020, THE PATIENT UNDERWENT A TIBIAL NAIL EXCHANGE DUE TO A NONUNION. THE PROCEDURE OUTCOME AND THE PATIENT'S STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1)10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375 MM-STERILE. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11014854 ↗
• InjuryDec 10, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TITANIUM CANNULATED TIBIAL NAIL-EX WITH PROXIMAL BEND WAS BENT AND REMOVED FROM PATIENT. THE NAIL WAS BENT DUE TO A CAR ACCIDENT. IT IS UNKNOWN IF PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10985148 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT TIBIAL REVISION SURGERY DUE TO NON-UNION. SURGEON EXPLANTED THE TITANIUM CANNULATED TIBIAL NAIL AND PUT IN A NEW NAIL, AND ADDED A SMALL FRAGMENT PLATE AND SCREWS, AND HARVESTED BONE GRAFT USING RIA. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE. THIS IS REPORT 1 OF 7 FOR (B)(4).

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

  MAUDE report 10813124 ↗

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.