EXPert Nail 04.004.346SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982083913), received between Dec 28, 2017 and Aug 12, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY OF AN EXPERT TIBIAL NAIL ON (B)(6) 2024, AFTER THE FRACTURE HAD HEALED. THE PATIENT RECENTLY SUFFERED AN ACL RE-RUPTURE. AT THE SAME TIME, RELEVANT LATERAL ARTHROSIS WAS DIAGNOSED. THERE WAS NO INFECTION IDENTIFIED. THE NAIL WAS NOT ABLE TO BE REMOVED. PROCEDURE WAS COMPLETED WITH AN UNKNOWN DELAY. THIS REPORT IS FOR A 9MM TI CANNULATED TIBIAL NAIL-EX/330MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19964305 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT (B)(6) CLINICAL STUDY. RIGHT TIBIAL SHAFT FRACTURE RESULTED FROM A LOW ENERGY ACCIDENT ON (B)(6), 2020. FRACTURE WAS A CLOSED AO 42A1 CLASSIFIED TYPE II FRACTURE. A RIGHT FIBULA FRACTURE CLASSIFIED AS 4F2B WAS ALSO SUSTAINED. ON (B)(6) 2020 THE PATIENT WAS FIXED WITH AN EXTERNAL FIXATOR. ON (B)(6) 2020 OPEN REDUCTION INTERNAL FIXATION (ORIF) WAS COMPLETED WITH A TIBIAL NAIL AND SCREWS. PATIENT WAS DISCHARGED (B)(6) 2020. -FOLLOW UP WITH RADIOGRAPH IMAGES OCCURRED ON (B)(6) 2020 AND IT WAS NOTED BONE UNION HAD NOT BEEN ACHIEVED. -FOLLOW UP WITH RADIOGRAPH IMAGES OCCURRED ON (B)(6) 2020 AND IT WAS NOTED BONE UNION HAD NOT BEEN ACHIEVED. -ON (B)(6) 2021 IT WAS NOTED THE PATIENT HAD DIED DUE TO UNKNOWN CAUSES AND WAS LOST TO THE STUDY. POST OPERATIVE COMPLICATIONS FOR THE STUDY INVOLVED NON-UNION AS NO BONE UNION WAS EVER ACHIEVED FROM THE INITIAL SURGERY. NO REVISION SURGERY WAS EVER COMPLETED. THIS REPORT IS FOR ONE 9MM TI CANNULATED TIBIAL NAIL-EX/330MM-STERILE FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19239237 ↗
• InjuryDec 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY IMPLANTED WITH A TIBIAL NAIL AND FOUR UNKNOWN INTERLOCKING SCREWS ON AN UNKNOWN DATE AS TREATMENT FOR A FRACTURE. ON AN UNKNOWN DATE, POST-OPERATIVE, THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION. REPORTEDLY, THE PATIENT HAD REDNESS AND SWELLING AROUND THE INCISION SITE. IT IS UNKNOWN IF THE PATIENT HAD PAIN OR DISCOMFORT RELATED TO THIS EVENT. THE PATIENT HAD HARDWARE REMOVAL SURGERY ON (B)(6) 2017 THE TIBIAL NAIL AND FOUR UNKNOWN SCREWS WERE REMOVED INTACT. NO PATIENT HARM WAS REPORTED. CULTURES WERE COLLECTED DURING THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS REPORTED STABLE. THE EXPLANTED DEVICES WERE DISPOSED. THE PATIENT WILL BE RE-NAILED AT A FUTURE DATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7151243 ↗

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.