EXPert Nail 04.013.044Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982087423), received between Apr 17, 2018 and Apr 17, 2018 — 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 16, 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.

• InjuryApr 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL OF A HIND-FOOT NAIL TOOK PLACE ON (B)(6) 2018 DUE TO NONUNION OF SUBTALAR JOINT. THE NAIL WAS REMOVED, ILIAC BONE GRAFT WAS TAKEN TO GRAFT THE NONUNION AND 6.5/7.3 CANNULATED SCREWS WERE INSERTED FOR FIXATION. PROCEDURE COMPLETED SUCCESSFULLY WITH NO DELAY IN SURGERY. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7438743 ↗

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.