EXPert Nail 04.008.001SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982087157), received between Jun 18, 2019 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 24202327 ↗
• 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 24202325 ↗
• 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 24202318 ↗
• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A HIND FOOT ARTHRODESIS NAIL PROCEDURE, ONE (1) END CAP FOR HIND FOOT ARTHRODESIS NAIL TO LOCK THE HELICAL BLADE INTO THE HIND FOOT NAIL WAS NOT IN THE SET. A DIFFERENT END CAP WAS AVAILABLE IN THE SET, HOWEVER IT WAS FOR A RETROGRADE FEMORAL NAIL. IT WAS NOTED THIS FEMORAL NAIL END CAP WAS TOO LONG FOR THE SURGICAL NEED AND DID NOT FIT PROPERLY IN THE NAIL OR IN THE PATIENT. THERE WAS A DISTAL PROMINENCE THAT DID NOT ALLOW THE SCREW THREADS OF THE END CAP TO MATE WITH THE HIND FOOT NAIL. THE SURGEON PROCEEDED WITH THE AVAILABLE END CAP AND EVENTUALLY PLACED THE SECOND UNKNOWN SCREW IN THE CALCANEUS ABOVE THE HELICAL BLADE AND CUT THE PROMINENCE OFF OF THE END CAP WITH BOLT CUTTERS, ALLOWING AT LEAST A FEW THREADS TO ENGAGE THUS WORKING TO STABILIZE THE HELICAL BLADE AND PREVENT IT FROM BACKING OUT. AFTER CUTTING TIP OF END CAP AND REINFORCING CONSTRUCT WITH SCREW IT WAS STILL NOT POSSIBLE TO FULLY MAKE THE END CAP FLUSH WITH THE CONSTRUCT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF APPROXIMATELY 15-20 MINUTES. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUA

  Patient problems: No Code Available

  MAUDE report 8707714 ↗

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