EXPert Nail 04.013.448SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982087867), received between Apr 12, 2021 and Apr 12, 2021 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K033618); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THE RETROGRADE FEMORAL NAIL WAS BROKEN. THE NAIL BROKE AT THE JUNCTION OF THE SECOND LOCKING HOLE AFTER THE SPIRAL BLADE, BECAUSE OF A THREE-YEAR-OLD NON-UNION. THE ORIGINAL SURGERY WAS ON (B)(6) 2018 WITH PERIPROSTHETIC DISTAL FEMORAL FRACTURE WITH LONG RETROGRADE NAIL/SPIRAL BLADE. SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: TITANIUM SPIRAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), TITANIUM END CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), AND TITANIUM LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 10 TI CANN RETRO/ANTEGRADE FEM NL/340-S. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11651549 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033618. One submission often covers many models, so check the product and lot details in each record.

• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.