EXPert Nail 04.008.000SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982087133), received between Nov 20, 2020 and Jan 28, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IT WAS IDENTIFIED THAT THE DEVICE IS UNABLE TO STERILIZE/ASSEMBLE. IT IS CHIPPING AND CRACKING AND UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202320 ↗
• MalfunctionJan 28, 2026Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IT WAS IDENTIFIED THAT THE DEVICE IS UNABLE TO STERILIZE/ASSEMBLE. IT IS CHIPPING AND CRACKING AND UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202317 ↗
• MalfunctionJan 28, 2026Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IT WAS IDENTIFIED THAT THE DEVICE IS UNABLE TO STERILIZE/ASSEMBLE. IT IS CHIPPING AND CRACKING AND UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202315 ↗
• 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 END CAP F/HAN TAN GOLD. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10877042 ↗

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