EXPert Nail 04.004.446SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982084194), received between Jul 19, 2021 and Jul 19, 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.

• MalfunctionJul 19, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT FOR A PROCEDURE. DURING THE PROCEDURE, WHILE REAMING A SUPRAPATELLAR TIBIAL NAIL, THERE WAS DIFFICULTY TO CATCHING THE FLEXIBLE REAMERS ON THE PROTECTION SLEEVE WHEN RETRACTING FLEXIBLE REAMER. FURTHERMORE, WHEN DRILLING FOR THE S1 PROXIMAL INTERLOCKING SCREW, THE DRILL BIT WOULD NOT PASS THROUGH THE NAIL AND UNABLE TO PLACE A SCREW THROUGH THE DESIRED HOLE. THE S2 PROXIMAL INTERLOCKING SCREW WAS SUCCESSFULLY DRILLED AND INSERTED ALONG WITH ANOTHER PROXIMAL OBLIQUE SCREW. THERE WAS 10 MINUTES OF SURGICAL DELAY NOTED. NO FRAGMENTS GENERATED NOTED. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNK - INSERTION INSTRUMENTS: TRAUMA :PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). UNK - REAMING RODS :PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 10 TI CANNULATED TIBIAL NAIL-EX/330-SILE. THIS REPORT IS 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188888 ↗

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.