EXPert Nail 04.004.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982083371), received between Oct 1, 2018 and May 27, 2021 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A NON-UNION OF THE LEFT TIBIAL SHAFT. THE IMPLANTS THAT WERE REMOVED WERE TITANIUM CANNULATED TIBIAL NAIL, END CAP, AND THREE TITANIUM LOCKING SCREWS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11894487 ↗
• InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT THE REMOVAL OF ONE (1) TITANIUM CANNULATED TIBIAL NAIL, TWO (2) UNKNOWN DUAL-CORE SCREWS, TWELVE (12) UNKNOWN LOCKING SCREWS, ONE (1) TI END CAP AND ONE (1) TOMOFIX P TIBIAL HEAD PLATE DUE INFECTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX. THIS IS REPORT 3 OF 10 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11425323 ↗
• MalfunctionFeb 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, AN ORTHOPEDIC PROCEDURE WAS PERFORMED FOR UNKNOWN REASON. END CAP WOULD NOT THREAD ONTO NAIL. REPLACED WITH A NEW END CAP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS A SURGICAL DELAY OF 5 MINUTES. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX. THIS IS REPORT 1 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11303908 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION AND HARDWARE REMOVAL. THE REVISION SURGERY WAS DUE TO INFECTION AND NON-UNION OF TWO (2) CORTEX SCREWS, ONE (1) TITANIUM CANNULATED TIBIAL NAIL-EX WITH PROXIMAL BEND, FOUR (4) TITANIUM LOCKING SCREW AND ONE (1) TITANIUM END CAP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 3.5MM CORTEX SCREW SELF-TAPPING 40MM (PART NUMBER 204.84, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 44MM (PART NUMBER 204.844, LOT UNKNOWN, QUANTITY 1), 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE (PART NUMBER 04.034.449S, LOT 22P4336, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS (PART NUMBER 04.005.524, LOT UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS (PART NUMBER 04.005.530, LOT UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS (PART NUMBER 04.005.528, LOT UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS (PART NUMBER 04.005.526, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX.

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

  MAUDE report 10108225 ↗
• InjuryOct 1, 2018No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT IMPLANT PROCEDURE IN (B)(6). POST-OPERATIVE, ON (B)(6) 2018, PATIENT UNDERWENT HARDWARE REMOVAL DUE TO INFECTION AND NON-UNION. DURING THE REMOVAL, THE TITANIUM (TI) CANNULATED TIBIAL NAIL-EX, TI END CAP AND TWO (2) PROXIMAL SCREWS WERE REMOVED. THE TIBIA WAS REAMED, AND THEN TISSUE SPECIMENS WERE COLLECTED AND SENT TO THE LABORATORY. ANTIBIOTIC BEADS WERE APPLIED AS A TREATMENT FOR THE INFECTION. PATIENT OUTCOME WAS UNKNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7922588 ↗

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.