EXPert Nail 04.034.649SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982095503), received between Apr 9, 2019 and May 26, 2021 — classified as 2 injuries.

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 16, 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.

• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO INFECTION. THE HARDWARE REMOVAL OF A SYNTHES TIBIAL NAIL AND UNKNOWN TOTAL KNEE IMPLANTS. THE TIBIA AND THE KNEE WERE GROSSLY INFECTED. THE TIBIAL NAIL WAS PLACED AT AN UNKNOWN TIME AND PLACE. THE HARDWARE WAS REMOVED SUCCESSFULLY, AND TWO HUMERAL NAILS WERE WRAPPED IN CEMENT AND USED AS ANTIBIOTIC SPACERS. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 12MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM. THIS REPORT IS 1 OF 4 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890398 ↗
• InjuryApr 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD OPEN REDUCTION AND INTERNAL FIXATION (ORIF) ON AN UNKNOWN DATE IN 2012. ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL OF A TIBIAL NAIL, LOCKING SCREW 72MM, LOCKING SCREW 40MM, TWO (2) LOCKING SCREW 36MM, AND LOCKING SCREW 46MM DUE TO PARTIAL NON-UNION, DELAYED HEALING, INFLAMMATION AND INFECTION.  THERE WAS NO SURGICAL DELAY.  PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS SATISFACTORY. THIS REPORT IS FOR ONE (1) TIBIAL NAIL. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Inflammation; No Code Available; Unspecified Infection

  MAUDE report 8496516 ↗

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.