EXPert Nail 04.013.764SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982088413), received between Dec 11, 2018 and Apr 10, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT HARDWARE REMOVAL DEEP DUE TO RIGHT FEMUR PAINFUL HARDWARE. THE PLATE SCREWS AND STIMULATOR BODIES WERE REMOVED. THE STIMULATOR ELECTRODES WERE ENCASED IN BONE AND WERE NOT EXTRACTED. THIS REPORT IS FOR ONE (1) 13 TI CANN RETRO/ANTEGRADE FEM NL/420-S. THIS IS REPORT 1 OF 12 FOR COMPLAINT (B)(4) . .

  Patient problems: Pain

  MAUDE report 16709582 ↗
• MalfunctionDec 11, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR ON AN UNKNOWN DATE, THE DRILL SLEEVE MISSED THE RETRO/ANTEGRADE FEMORAL NAIL (AFN). ANOTHER NAIL WAS USED TO COMPLETE THE PROCEDURE. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 13MM TITANIUM (TI) CANNULATED RETRO/ANTEGRADE FEMORAL NAIL 420MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8152472 ↗

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.