EXPert Nail 04.004.458SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982084279), received between Jul 11, 2018 and May 15, 2024 — 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 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.

• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). IT WAS REPORTED THAT THE PATIENT UNDERWENT A SUBSEQUENT REVISION SURGERY ON (B)(6) 2021 DUE TO SECONDARY LOSS OF REDUCTION. THE ORIGINAL IMPLANT DATE WAS FROM THE PREVIOUS REVISION ON (B)(6) 2021. PATIENT HAD PREVIOUSLY EXPERIENCED NON-UNION FROM THE INITIAL SURGERY CONDUCTED ON (B)(6) 2020. HARDWARE; TIBIAL NAIL, 1 PROXIMAL DYNAMIC INTERLOCKING SCREW, 3 DISTAL STATIC INTERLOCKING SCREWS WERE REMOVED. IRRIGATION AND INSTALLATION OF A REDON DRAINAGE WAS COMPLETED. THIS REPORT IS FOR ONE EXPERT TIBIAL NAIL PROTECT Ø10 CANN L390 FOR (B)(4) (B)(4) IS LINKED TO (B)(4). (B)(4) IS FOR THE INITIAL REVISION DUE TO NON UNION. (B)(4) IS FOR THE SECOND REVISION DUE TO LOSS OF REDUCTION.

  Patient problems: Physical Asymmetry

  MAUDE report 19322958 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF HARDWARE ON (B)(6) 2018 DUE TO INFECTION CAUSED BY THE FEMUR IMPLANTS AND PAIN CAUSED BY THE TIBIAL IMPLANTS. IMPLANTS WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. DEVICES REMOVED ARE ONE (1) TITANIUM CANNULATED TIBIAL NAIL, ONE (1) TITANIUM END CAP, TWO (2) TITANIUM LOCKING SCREW, ONE (1) LOCKING COMPRESSION (LCP) CURVED CONDYLAR PLATE, ONE (1) PERIPROSTHETIC LOCKING SCREW, ONE (1) LOCKING SCREW, EIGHT (8) CORTEX SCREWS, AND TWO (2) CANNULATED SCREW PARTIALLY THREADED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TOTAL 17 DEVICES. COMPLAINT (B)(4) CAPTURES 10 DEVICES. THE REMAINING 7 DEVICES HAVE BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 10MM TI CANNULATED TIBIAL NAIL-EX/390MM-STERILE THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7679670 ↗

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.