EXPert Nail 04.004.243SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982083616), received between Aug 7, 2018 and Jan 12, 2024 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CONSEQUENCES WERE REPORTED AS PROLONGED HOSPITALIZATION, ANTIBIOTICS AND WOUND DRESSINGS, PATIENT RECOVERED WITHOUT PERSISTENT DAMAGE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18503993 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CONSEQUENCES WERE REPORTED AS PROLONGED HOSPITALIZATION, ANTIBIOTICS AND WOUND DRESSINGS, PATIENT RECOVERED WITHOUT PERSISTENT DAMAGE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18503989 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DISCOMFORT DUE TO A TIBIAL NAIL PROMINENCE IN THE KNEE AND DELAYED UNION. AN EXCHANGE NAIL WILL BE DONE ON (B)(6) 2018. THIS REPORT IS FOR ONE (1) 8MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Discomfort; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8042881 ↗
• InjuryAug 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS SCHEDULED TO UNDERGO REVISION ON (B)(6) 2018, TO REMOVE THE FOLLOWING HARDWARE: ONE (1) TITANIUM CANNULATED TIBIAL NAIL, ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE 6 HOLES, ONE (1) TITANIUM LOCKING SCREW 60MM, ONE (1) TITANIUM LOCKING SCREW 76MM, ONE (1) TITANIUM LOCKING SCREW 30MM, ONE (1) TITANIUM LOCKING SCREW 50MM AND ONE (1) CORTEX SCREW SELF-TAPPING, DUE TO OSTEOMYELITIS. THE HARDWARE WAS ORIGINALLY IMPLANTED FOR A FRACTURE REPAIR SURGERY TO THE RIGHT TIBIA ON AN UNKNOWN DATE IN 2017. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7758130 ↗

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.