EXPert Nail 04.013.460SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982087898), received between Oct 1, 2021 and Oct 1, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K033618); 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.

• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF ADVANCED RETROGRADE FEMORAL NAILING (RFNA) NAIL AND TWO 5MM LOCKING SCREWS DUE TO NONUNION OF A RIGHT FEMORAL FRACTURE. SURGEON REMOVED IMPLANTS WITHOUT INCIDENT, THEN USED A REAMER IRRIGATOR ASPIRATOR (RIA) TO COLLECT BONE GRAFT. SURGEON THEN IMPLANTED A NEW ADVANCED RETROGRADE FEMORAL NAILING (RFNA) NAIL AFTER CORRECTING ALIGNMENT AND PLACED BONE GRAFT IN THE NONUNION SITE. PATIENT EXPERIENCED DELAYED HEALING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR A 10MM TITANIUM (TI) CANNULATED RETRO/ANTEGRADE FEMORAL NAIL-EX. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12564409 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033618. One submission often covers many models, so check the product and lot details in each record.

• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.