EXPert Nail 04.004.552SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982084514), received between Mar 31, 2020 and Mar 31, 2020 — classified as 1 injury.

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.

• InjuryMar 31, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF TITANIUM CANNULATED TIBIAL NAIL, TITANIUM LOCKING SCREW 42MM AND TITANIUM LOCKING SCREW 34MM DUE TO HYPERTROPHIC NONUNION 15 MONTHS POSTOPERATIVELY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 11MM TI CANNULATED TIBIAL NAIL-EX/ 360MM-STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 9904207 ↗

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.