EXPert Nail 04.013.656SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982088222), received between Jul 23, 2019 and Oct 25, 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.

• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT HAD A NONUNION FROM A PREVIOUS SURGERY, SO THIS WAS A REVISION SURGERY. PREVIOUS RAFN NAIL AND SCREWS WERE REMOVED. REMOVAL WAS UNEVENTFUL, AND SUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 12MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE. THIS IS REPORT 7 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15666598 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 8816316 ↗

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.