EXPert Nail 04.013.648SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982088208), received between Aug 28, 2019 and Aug 28, 2019 — 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.

• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT UNDERWENT REMOVAL OF NAIL DUE TO NONUNION AND DELAYED HEALING. ALL HARDWARE WAS INTACT. PATIENT WAS REVISED TO A PLATE. IT WAS NOTED PATIENT POOR BONE QUALITY AND FRACTURE PATTERN. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 6 FOR (B)(4).

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

  MAUDE report 8940234 ↗

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.