EXPert Nail 04.013.760SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982088406), received between Dec 1, 2021 and Dec 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.

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

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY. DURING THE PROCEDURE, THE INFECTED RETROGRADE NAIL WAS REMOVED AND RFNA WAS INSERTED. ALL ITEMS REMOVED WERE INTACT. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 13 TI CANN RETRO/ANTEGRADE FEM NL/400-S. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 12911017 ↗

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.