EXPert Nail 04.008.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982087126), received between Apr 17, 2018 and Jul 18, 2018 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH ONE (1) 12MM HINDFOOT ARTHRODESIS CANNULATED NAIL, ONE (1) SPIRAL BLADE, ONE (1) END CAP, TWO (2) UNKNOWN 5MM LOCKING SCREWS, AND ONE (1) UNKNOWN 6MM LOCKING SCREW ON (B)(6) 2017. ON UNKNOWN DATE, PATIENT DEVELOPED AVASCULAR NECROSIS (AVN) AND NON-UNION. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. PATIENT WAS REVISED TO ONE (1) 4MM CANNULATED SCREW AND ONE (1) 6.5MM CANNULATED SCREW. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT STATUS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) END CAP FOR HINDFOOT ARTHRODESIS NAIL THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7698587 ↗
• 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 3 OF 4 FOR (B)(4).

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

  MAUDE report 7438740 ↗

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