EXPert Nail 04.034.346SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982095107), received between Jan 29, 2018 and May 10, 2021 — 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.

• InjuryMay 10, 2021Adverse 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 UNDERWENT REMOVAL OF TITANIUM CANNULATED TIBIAL NAIL WITH PROXIMAL BEND AND SIX (6) TITANIUM LOCKING SCREWS DUE TO NONUNION. ALL HARDWARE WAS SUCCESSFULLY REMOVED INTACT. THE REAMER IRRIGATOR ASPIRATOR (RIA) 2 REAMER HEAD BROKE OFF DURING REAMING. PATIENT OUTCOME WAS UNKNOWN. THIS (B)(4) CAPTURES THE POSTOP EVENT REMOVAL, DUE TO NONUNION. (B)(4) CAPTURES THE INTRA-OP EVENT DURING REMOVAL WHEN THE REAMER HEAD BROKE OFF. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR ONE (1) 9 TI CANN TIBIAL NAIL-EX PROX BEND 330-S THIS REPORT IS 3 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11802798 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT REMOVAL OF A 9MM TITANIUM CANNULATED TIBIAL WAS REVISED TO AN 11MM TIBIAL NAIL DUE TO A PROXIMAL THIRD FRACTURE LINE IN THE TIBIA. THERE WERE NO BROKEN SCREWS OR IMPLANTS REPORTED. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 9MM TITANIUM (TI) CANNULATED TIBIAL NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 8134555 ↗
• InjuryJan 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A RIGHT TIBIA SHAFT NON-UNION, FOUR BROKEN TITANIUM LOCKING SCREWS AND A POSSIBLE INFECTION UNDERWENT A TIBIA NAIL- EXPERT HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2018. THE SURGEON OPENED THE NON-UNION SITE, RETRIEVED CULTURE SAMPLES AND REMOVED NON-UNION BONE. ALL SCREWS AND BROKEN PIECES WERE REMOVED (DISTAL BROKEN X 4, PROXIMAL INTACT X 2). AN EXPERT TIBIA NAIL (9MM X 360MM) WAS REMOVED. A NEW EXPERT NAIL WAS IMPLANTED (10MM X 360MM) WITH THREE DISTAL SCREWS AND TWO PROXIMAL, ANTIBIOTIC CEMENT WAS PLACED AT THE NON-UNION SITE. THE ORIGINAL IMPLANT DATE IS UNKNOWN. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAYS. THE PREVIOUSLY IMPLANTED HARDWARE WAS REMOVED EASILY. THE DEVICES ARE NOT AVAILABLE FOR INVESTIGATION BUT PHOTOS OF THE SCREWS WERE FORWARDED FOR INVESTIGATION. THIS REPORT IS FOR ONE (1) 9MM TIBIAL NAIL-EX. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7226160 ↗

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.