EXPert Nail 04.004.002SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982083425), received between Apr 29, 2020 and Oct 6, 2020 — 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.

• MalfunctionOct 6, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, THE TITANIUM END CAP WITH T40 STARDRIVE 10MM EXT-STERILE FOR TITANIUM NAIL-EX WOULD NOT SEAT IN NAIL. AFTER MULTIPLE ATTEMPTS OF THE SURGEON AND LOOKED AT IT AND SAW THAT THE THREADS WERE FAULTY ON THE END CAP. THE SURGEON ENDED UP NOT PUTTING AN END CAP IN AFTER THE FAILED ATTEMPTS AND CONTINUED ON WITH THE DISTAL LOCKING OF THE NAIL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE IS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10634950 ↗
• MalfunctionApr 29, 2020Naturally Worn; Material Split, Cut or Torn; Naturally Worn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TI END CAP WITH T40 STARDRIVE 10MM WAS STRIPPING AND WOULD NOT ALLOW FOR INSERTION, JUST USED AN END CAP THAT PROPERLY THREADED INTO THE NAIL. A DIFFERENT END CAP HAD TO BE USED INSTEAD. NO FRAGMENTS GENERATED. NO SURGICAL DELAY. PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10011564 ↗

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.