EXPert Nail 04.034.249SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982094988), received between Sep 1, 2020 and Sep 3, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, WHILE DOING A TIBIAL NAIL PROCEDURE, THE TIBIAL NAIL WAS DOING FINE BUT UPON EXTRACTING THE INSERTION HANDLE IT WAS FOUND TO BE ALMOST COLD-WELDED. THE INSERTION HANDLE WAS STUCK FOR TEN (10) MINUTES BEFORE IT BECAME UNLOCKED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THIS REPORT IS FOR ONE (1) 8MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10491010 ↗
• MalfunctionSep 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A TRAUMA PROCEDURE. THE SURGEON COMPLETED BACK TO BACK TIBIAL NAILS AND WAS ATTEMPTING DIFFERENT ANGLES AND LEVERAGE OPTIONS TO AID IN REMOVAL. THE SURGEON HAD DIFFICULTY DISENGAGING THE NAIL FROM THE INSERTION HANDLE. HE USED THE SCREWDRIVER BALL HEXAGONAL TO REMOVE THE CONNECTING SCREW. THE T-HANDLE BALL HEXAGONAL SCREWDRIVER HAD NO MOVEMENT OF THE CONNECTING SCREW AND IT SEEMED THAT THE INTERFACE WAS COLD-WELDED. AFTER A FEW ATTEMPTS, THERE WAS SOME LOOSENING OF SOME OF THE TREADS AND IT STARTED TO BACK OUT. THE TOOTH OF THE INSERTION HANDLE HAD BECOME DISENGAGED FROM THE NAIL BUT THREADS OF THE INSERTION SCREW WERE STILL THREADED INTO THE NAIL. BENDING THE KNEE AT A 45-DEGREE ANGLE AND MALLET BLOWS FROM UNDER THE HANDLE WHILE USING THE COMBINATION WRENCH ON THE SCREWDRIVER AIDED IN THE REMOVAL OF THE INSERTION SCREW AND INSERTION HANDLE. UPON INSPECTION, THERE WAS NO THREAD DAMAGE TO THE SCREW BUT THERE WAS SOME DAMAGE TO THE TOOTH OF THE INSERTION HANDLE. FRAGMENTS WERE GENERATED BUT THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. ADDITIONAL X-RAYS WERE NEEDED TO DETERMINE IF THE SCREW WAS BACKING OUT OF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10478094 ↗

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.