EXPert Nail 04.008.078SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982087218), received between Nov 19, 2019 and Nov 20, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

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.

• InjuryNov 20, 2020Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY AROUND 9PM TO REPOSITION THE EXPERT HAN NAIL, EXPERT END CAP, SPIRAL BLADE, AND THREE (3) LOCKING SCREWS. THE ORIGINAL PROCEDURE WAS COMPLETED ON (B)(6) 2020 IN THE AFTERNOON. THE SURGEON ORIGINALLY PLACED THE EXPERT HAN NAIL BUT DIAGNOSTIC IMAGING SHOWED EVIDENCE THAT THE EXPERT HAN NAIL REMAINED EXTRAMEDULLARY IN THE MID-DISTAL THIRD OF THE TIBIA. THIS REQUIRED REVISION SURGERY TO CARRY OUT REPOSITIONING OF THE IMPLANTS. THERE WAS PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) EXPERT HAN 10 LE CANN L240 TAN LIGHT GR. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10876960 ↗
• InjuryNov 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 A REVISION SURGERY DUE TO CHRONIC OSTEOMYELITIS, INFECTION, INFLAMMATION, NONUNION OF JOINT, AND DELAYED HEALING. ONE (1) HINDFOOT NAIL, ONE (1) SPIRAL BLADE, ONE (1) 6MM UNKNOWN LOCKING SCREW, AND ONE (1) 5MM UNKNOWN LOCKING SCREW WERE REMOVED. ALL HARDWARE WAS INTACT. AFTER THE REMOVAL, THE EXTREMITY OF THE PATIENT WAS I&D USING RIA. THERE WAS NO SURGICAL DELAY.  IT IS UNKNOWN IF PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS GOOD. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS IS 1 OF 4 FOR REPORT (B)(4).

  Patient problems: Inflammation; No Code Available; Unspecified Infection

  MAUDE report 9342513 ↗

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