EXPert Nail 04.034.355SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982095138), received between Dec 11, 2020 and Mar 31, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 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.

• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE ON (B)(6) 2020 DUE TO NONUNION. THE PRIMARY SURGERY WAS DONE ON (B)(6) 2020, TO TREAT TIBIAL FRACTURE DUE TO A TRAFFIC ACCIDENT. THE IMPLANTS WERE REMOVED WITH THE REGULAR TEST BUT WITHOUT CULTURES. THE SURGERY WAS SUCCESSFUL. THE PATIENT STATUS IS STABLE AND WAS DISCHARGED ON (B)(6) 2020, AND THE LAST CLINIC FOLLOW-UP WAS ON (B)(6) 2021, WITH SATISFACTORY HEALING. THIS REPORT IS FOR (1) 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13970607 ↗
• InjuryJan 11, 2022Adverse 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 A HARDWARE REMOVAL DUE TO NONUNION AT FRACTURE SITE. SURGEON REMOVED AN EX TIBIAL NAIL AND 4 INTERLOCKING SCREWS. PATIENT WAS REVISED TO ANOTHER COMPANIES PRODUCTS. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR (1) 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13232390 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE HARDWARE FOR A FRACTURE OF RIGHT TIBIAL IMPLANTS WAS REMOVED DUE TO THE INFECTION. THE FOLLOWING IMPLANTS WERE REMOVED, ONE (1) 4.0MM TITANIUM LOCKING SCREWS, TWO (2) 4.0MM TITANIUM LOCKING SCREWS, AND ONE (1) TITANIUM CANNULATED TIBIAL NAIL AND ALL WERE INTACT(NO BROKEN IMPLANTS AND NO FRAGMENTS). PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS DOING WELL POST-OPERATIVELY. CONCOMITANT DEVICE REPORTED: 4.0MM TITANIUM LOCKING SCREWS (PART:04.005.434;LOT:UNKNOWN; QUANTITY:1). 4.0MM TITANIUM LOCKING SCREWS (PART:04.005.436;LOT:UNKNOWN; QUANTITY:1). THIS REPORT IS FOR ONE (1) 9 TI CANN TIBIAL NAIL-EX PROX BEND 375-S. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12521596 ↗
• MalfunctionDec 11, 2020Nonstandard Device; Device-Device Incompatibility; Nonstandard Device; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 9 X 375MM EXPERT TIBIAL NAIL WITH PROXIMAL BEND WAS OPENED IN A CASE, THE NAIL SHOULD HAVE BEEN BLUE BUT IT WAS GREEN. THE 5MM AND 4MM SCREWS WERE CHECKED AND IT WAS CONFIRMED THAT ONLY THE 4MM SCREWS FIT THROUGH THE NAIL WHICH IS IN THE KEEPING OF THE 9MM NAIL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: SCREWS: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10992096 ↗

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.