EXPert Nail 04.004.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982083432), received between Oct 12, 2018 and Oct 12, 2018 — classified as 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 18, 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.

• MalfunctionOct 12, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE TITANIUM END CAP DID NOT INSERT INTO AN UNKNOWN TIBIAL NAIL AND DID NOT STOP SPINNING. UPON ASSESSMENT USING AN INTR-OPERATIVE X-RAY, THE SURGEON NOTED THAT THE TITANIUM END CAP WAS IN THE NAIL BUT WOULD NOT LOCK IN. SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 3 MINUTES. CONCOMITANT DEVICE: TIBIAL NAIL (PART 04.004.353S, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) END CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7963349 ↗

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.