EXPert Nail 04.004.009SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982083487), received between May 25, 2018 and May 25, 2018 — 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.

• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018, TO REMOVE FIVE (5) TITANIUM LOCKING SCREWS, AN 11MM TITANIUM CANNULATED TIBIAL NAIL AND A TITANIUM END CAP DUE TO DELAYED HEALING AND A NON-UNION. IT ORIGINAL IMPLANT DATE OF THE EXPLANTED DEVICES IS UNKNOWN AT THIS TIME. THE PATIENT WAS REVISED TO A LARGER 13MM TIBIAL NAIL AND USED A LOCKING SCREW ON THE LATERAL SIDE TO AID WITH PROPER REDUCTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAYS AND NO ADDITIONAL MEDICAL INTERVENTION REQUIRED DURING THE PROCEDURE. NO PATIENT OUTCOME REPORTED. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7546121 ↗

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.