EXPert Nail 04.013.560SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982088062), received between Sep 4, 2018 and Sep 4, 2018 — classified as 1 injury.

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.

• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL OF A TITANIUM CANNULATED RETRO/ANTEGRADE FEMORAL NAIL AND (3) UNKNOWN SCREWS DUE TO NON-UNION. THE HARDWARE WAS ORIGINALLY IMPLANTED ON AN UNKNOWN DATE IN (B)(6) 2018 AS A SECOND SURGERY. NO DETAILS ON THE FIRST SURGERY HAVE BEEN PROVIDED. DURING THE PROCEDURE, THE EXTRACTOR DID NOT WORK, AND ANOTHER SET WAS OPENED TO COMPLETE THE PROCEDURE. THE REMOVAL WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT ADDRESSES THE POST-OPERATIVE EVENT OF HARDWARE REMOVAL DUE TO NON-UNION. THE INTRA-OPERATIVE EVENT HAS BEEN REPORTED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR A 11MM TITANIUM (TI) CANNULATED RETROGRADE/ANTEGRADE FEMORAL NAIL-EX/400MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 7841740 ↗

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.