EXPert Nail 04.004.561SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982084576), received between Aug 6, 2021 and Aug 6, 2021 — 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.

• MalfunctionAug 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, WHILE DRILLING THE PROXIMAL SCREW THE DRILL BIT HIT THE NAIL. THE SURGEON WAS ABLE TO TARGET THE HOLE AND THE SCREW WAS ACCURATELY PLACED. CHECKED POSTOPERATIVE AND IT WAS NOTED THAT THE HOLES IN THE GUIDE LINE UP WITH THE HOLES IN THE TIBIAL NAILS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) 11MM TI CANNULATED TIBIAL NAIL-EX/405MM-STERILE. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288975 ↗

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.