EXPert Nail 04.008.216SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982087232), received between Jul 18, 2018 and May 24, 2022 — 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.

• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT A REMOVAL OF HINDFOOT NAIL(1), TWO (2) UNKNOWN SCREWS: 6.0MM, TWO(2) UNKNOWN SCREWS: 5.0MM AND TWO(2) UNKNOWN SCREWS: 4.5MM FOR UNKNOWN REASON. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT'S OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK SCREWS: FOOT (6.0MM) (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 2). UNK SCREWS: FOOT (5.0MM) (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 2) UNK SCREWS: 4.5 MM CANNULATED (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 2). THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A HINDFOOT NAIL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14487476 ↗
• 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) 12 MM HINDFOOT ARTHRODESIS CANNULATED NAIL, ONE (1) SPIRAL BLADE, ONE (1) END CAP, TWO (2) UNKNOWN 5 MM LOCKING SCREWS, AND ONE (1) UNKNOWN 6 MM 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) 4 MM CANNULATED SCREW AND ONE (1) 6.5 MM CANNULATED SCREW. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT STATUS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 12 MM HINDFOOT ARTHRODIESIS CANNULATED NAIL. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7698347 ↗

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