EXPert Nail 04.034.340SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982095084), received between Nov 19, 2020 and Nov 19, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE 9MM TITANIUM CANNULATED NAIL-EX WITH PROXIMAL BEND 300MM STERILE WAS OCCURRED AFTER INSERTED THE NAIL AND LOCKED IT UP, THEY WENT TO REMOVE THE NAIL AND NOT ABLE TO NAIL IT SINCE IT WAS IN A NORMAL PRESSURE FROM THE KNEE OF CROSS THREADING. THEY WERE ABLE TO REMOVE THE INSERTION HANDLE EXCEPT REMOVING THE NAIL ENTIRELY AND WAS REALIZE THAT THE NAIL ITSELF WAS BROKEN RIGHT UP THE NOTCH, WE HAVE TO REAMED UP AND UPSIZE THE NAIL AND IMPLANTED 10 X 300MM. THERE WAS A SURGICAL DELAY ADDED ABOUT FORTY (40) MINUTES TO THE SURGICAL TIME SINCE THEY HAD TO REMOVE AND REINSERT TIBIAL NAIL. THERE WERE NO FRAGMENTS GENERATED BUT THE REMOVAL OF THE BROKEN, DAMAGED DEVICE OR FRAGMENTS HAD SOME DIFFICULTY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION INSTRUMENTS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 300MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10868881 ↗

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.