EXPert Nail 04.004.343SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982083890), received between Aug 14, 2018 and Feb 7, 2023 — classified as 2 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, DURING A TIBIAL NAIL, THE SURGEON WAS UNABLE TO SEPARATE THE NAIL FROM THE INSERTION HANDLE AT THE END OF THE CASE. AFTER REPEATED ATTEMPTS THE SURGEON WAS FORCED TO REMOVE THE NAIL AND HARDWARE AND INSERT A NEW NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 60 MINUTES. THE PATIENT STATUS/OUTCOME WAS POSITIVE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 9 TI CANNULATED TIBIAL NAIL-EX/315-SILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315970 ↗
• MalfunctionAug 14, 2018Fracture; Material Deformation; Fracture; Material Deformation

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A DIAPHYSEAL FRACTURE LEFT TIBIA PROCEDURE ON AN UNKNOWN DATE, THE UPPER PART OF A 9MM TITANIUM CANNULATED TIBIAL NAIL WHICH WAS ANCHORED TO THE INSERTION HANDLE, CEDED AND WAS DEFORMED DURING INSERTION OF THE NAIL, ALLOWING A WIDE RANGE OF MOVEMENT AND ALTERING THE INSERTION PROCESS. IT WAS UNKNOWN IF ANOTHER NAIL WAS USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING THE SAME INSERTION HANDLE. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME IS GOOD. CONCOMITANT DEVICE REPORTED: INSERTION HANDLE (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN) THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7780822 ↗

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.