EXPert Nail 04.008.010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982087164), received between Jun 19, 2019 and Jun 19, 2019 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K051678); 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.

• InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF ONE (1) HINDFOOT ARTHRODESIS NAIL, TWO (2) 5.0 SCREWS AND TWO (2) 6.0 SCREWS DUE TO THE TIBIA THAT BROKE AT THE PROXIMAL SCREW HOLE JUNCTION. PATIENT WAS REVISED TO A NEW NAILS AND SCREWS. ORIGINAL DATE OF IMPLANT IS (B)(6) 2019. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A 10MM TITANIUM (TI) HINDFOOT ARTHRODESIS CANNULATED NAIL. THIS IS REPORT 1 OF 3 FOR (B)(4).

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

  MAUDE report 8712259 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051678. One submission often covers many models, so check the product and lot details in each record.

• Z-1234-2024 · Jan 24, 2024 · Open, Classified
  13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability