EXPert Nail 04.001.410SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982080998), received between Jan 5, 2018 and Jan 5, 2018 — 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.

• InjuryJan 5, 2018Break; Break

  IT WAS REPORTED THAT AN EXPERT (EX) HUMERAL NAIL ORIGINALLY IMPLANTED ON (B)(6) 2017, HAS FAILED. THE PATIENT WAS REVISED BY REPLACING THE NAIL WITH A REVERSE TOTAL SHOULDER ON (B)(6) 2017. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT STATUS WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE (PART 351.706S, LOT H229233, QUANTITY 1); TI END CAP T25 STRDRV 0MM EXT- STER/HUMERAL NAIL-EX SPRL BLD (PART 04.001.000S, LOT 056614, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7169896 ↗

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.