EXPert Nail 04.004.546SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982084477), received between Aug 23, 2019 and Jul 16, 2020 — classified as 1 injury, 2 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K040762); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, DURING DRILLING FOR PROXIMAL UNKNOWN SCREWS, THE DRILL BIT WAS CONTACTED NAIL AND WITH AN UNKNOWN ISSUE. THE SURGEON SUCCESSFULLY PASSED THE UNKNOWN SCREW AND AFTER THE SURGERY, THE GUIDE/ DRILL SLEEVE LINED UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286007 ↗
• InjuryAug 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL OF TIBIAL INTRAMEDULLARY NAIL DUE TO NONUNION. WHILE REMOVING NAIL BROKE AND PIECE WAS LEFT IN PATIENT. THE FRAGMENTS WAS REMOVED EASILY, PROCEDURE WAS COMPLETED SUCCESSFULLY WITH LESS THAN 5 MINUTES SURGICAL DELAY. IM NAIL REMOVED AND PLATED DURING PROCEDURE. PATIENT OUTCOME IS UNKNOWN. THIS REPORT CAPTURES POST-OP EVENT OF HARDWARE REMOVAL DUE TO NON-UNION. RELATED COMPLAINT (B)(4) CAPTURES INTRA-OP EVENT OF NAIL BREAKAGE DURING REMOVAL. THIS REPORT IS FOR ONE (1) 11MM TI CANNULATED TIBIAL NAIL-EX/330MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8925803 ↗
• MalfunctionAug 23, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING THE REMOVAL PROCEDURE, WHILE REMOVING NAIL BROKE AND THE PIECE WAS LEFT IN THE PATIENT. THIS CAUSED A DELAY OF LESS THAN 5 MINUTES. PROCEDURE COMPLETED INTRAMEDULLARY NAIL REMOVED AND PLATED. PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 11MM TI CANNULATED TIBIAL NAIL-EX/330MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8925457 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040762. One submission often covers many models, so check the product and lot details in each record.

• Z-2051-2015 · Jun 3, 2015 · Terminated
  TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.