EXPert Nail 04.034.655SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982095527), received between Feb 15, 2019 and Nov 9, 2021 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT UNDERWENT A PROCEDURE TO TREAT THE DISTAL TIBIA AND FIBULA FRACTURE WITH A TIBIA NAIL AND FIBULA PLATE. THE PATIENT HAD ZERO HEALING PROPERTIES AND CONSEQUENTLY, THE PATIENTS DISTAL LEG WAS QUITE ROTTING OFF. ON (B)(6) 2021 THE TIBIA NAIL ALONG WITH FIVE (5) 5.0MM LOCKING SCREWS WERE REMOVED AND PATIENT'S LEG WAS AMPUTATED BELOW THE KNEE. CLINICAL OUTCOME EXPERIENCED BY THE PATIENT WAS INFECTION. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 12MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Necrosis; Unspecified Infection

  MAUDE report 12779331 ↗
• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT RE-OPERATION DUE TO BEING NON-COMPLIANT WITH THE PHYSICIAN'S INSTRUCTIONS WHICH RESULTED IN A NON-UNION FRACTURE. TITANIUM CANNULATED TIBIAL NAIL AND FOUR (4) LOCKING SCREWS WILL BE REMOVED. THERE WAS PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 12MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12666221 ↗
• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF EX TIBIAL NAIL AND FOUR (4) 5.0 MM SCREWS DUE TO INFECTION AND NON-UNION AND WAS REVISED TO AN EX RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN). ANTIBIOTICS WERE APPLIED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A 12MM TITANIUM (TI) CANNULATED TIBIAL NAIL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available; Unspecified Infection

  MAUDE report 8379065 ↗
• InjuryFeb 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  03/21/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON AN (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL OF A TITANIUM (TI) CANNULATED TIBIAL NAIL, TWO (2) SCREWS AND A TITANIUM END CAP DUE TO AN INFECTED NONUNION. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. ANTIBIOTICS APPLIED TO PATIENT IN REVISION SURGERY.

  Patient problems: Impaired Healing; No Code Available; Unspecified Infection

  MAUDE report 8343730 ↗

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.