EXPert Nail 04.004.249SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982083654), received between Apr 12, 2018 and Mar 18, 2021 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF BROKEN TI CANNULATED TIBIAL NAIL AT MOST PROXIMAL SCREW HOLE OF THE DISTAL SEGMENT OF NAIL. THE PATIENT WAS REVISED WITH A NEW TIBIAL NAIL AND UNDERWENT A BONE GRAFT PROCEDURE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 8MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11515364 ↗
• InjuryApr 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT WAS PRESENTED WITH A LEFT TIBIA AND FIBULA FRACTURE. THE SURGEON PLACED ONE LCP ONE-THIRD TUBULAR PLATE IN THE PATIENT WITH SEVEN (7) CORTICAL SCREWS AND ONE PARTIALLY THREADED CANCELLOUS SCREW. SHE ALSO INSERTED AN 8MM TI CANNULATED TIBIAL NAIL WITH TWO (2) LOCKING SCREWS (ONE DISTAL AND ONE PROXIMAL). IN (B)(6) 2018, THE PATIENT PRESENTED A NON-UNION OF THE LEFT TIBIA AND FIBULA. ON (B)(6) 2018 THE SURGEON REMOVED THE LCP ONE-THIRD TUBULAR PLATE AND THE PROXIMAL LOCKING SCREW TO PROMOTE HEALING. THE SURGERY WAS COMPLETED WITH NO DELAYS AND THERE WAS NOT HARM TO THE PATIENT. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 7425032 ↗

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.