EXPert Nail 04.004.558SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982084552), received between Mar 20, 2019 and Mar 20, 2019 — 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 20, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTED NON-UNION LEFT TIBIA. THE PATIENT WAS IMPLANTED WITH ONE (1) CANNULATED TIBIAL NAIL AND FIVE (5) 5.0MM LOCKING SCREWS FROM THE NAIL ON AN UNKNOWN DATE. THE PATIENT UNDERWENT INCISION AND DRAINAGE LEFT TIBIA POSSIBLE EXCHANGE NAILING. THERE WAS AN OPEN WOUND ON THE MEDIAL ASPECT OF THE TIBIA. THE WOUND WAS DEBRIDED AND IRRIGATED. ALL HARDWARE WAS REMOVED COMPLETELY AND NONE OF THE HARDWARE WAS BROKEN. NO ADDITIONAL TIME WAS NEEDED TO REMOVE THE HARDWARE. THE INFECTED FRACTURE SITE WAS DEBRIDED USING A 12MM REAMER IRRIGATOR ASPIRATOR. THE SURGEON ELECTED AN 8-HOLE LOCKING COMPRESSION PLATE (LCP) PLATE FOR TEMPORARY FIXATION ALONG WITH AN ANTIBIOTIC NAIL THAT THE SURGEON MADE. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS STABLE. THIS REPORT IS FOR ONE (1) 11MM TI CANNULATED TIBIAL NAIL-EX/390MM-STERILE THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8436706 ↗

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.