EXPert Nail 04.001.236SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982080943), received between May 24, 2021 and May 24, 2021 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (K033071); 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.

• InjuryMay 24, 2021Break; Break

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT REMOVAL SURGERY OF A BROKEN TITANIUM CANNULATED HUMERAL NAIL. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN SPIRAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN END CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR 1 7MM TI CANNULATED HUMERAL NAIL-EX/280MM-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11872507 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033071. One submission often covers many models, so check the product and lot details in each record.

• Z-0407-2014 · Jul 30, 2013 · Terminated
  Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.