EXPert Nail 04.013.660SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982088239), received between Jun 2, 2021 and Apr 29, 2022 — classified as 2 injuries.

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

• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT UNDERWENT A REMOVAL OF NAIL AND EXCHANGE WITH NEW NAIL DUE TO NEW TROCH FRACTURE. TWO (2) SCREWS WERE REMOVED. ONE SCREW (1) WAS FUND BROKEN DURING REMOVAL PROCEDURE. IT WAS NOTED THAT NOT ALL BROKEN FRAGMENTS WERE REMOVED. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 12MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/400MM-STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 14253309 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF NAILING DUE TO NON-UNION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THIS REPORT IS FOR (1) 12MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/400MM-STERILE. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11924973 ↗

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.