EXPert Nail 04.034.449SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982095244), received between Jun 19, 2018 and Jul 5, 2021 — classified as 7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT UNDERWENT A REVISION OF A TIBIAL SHAFT FRACTURE HYPERTROPHIC NON-UNION. THE HARDWARE WAS REMOVED WITHOUT COMPLICATIONS AND REVISED. ALL IMPLANTS WERE INTACT UPON REMOVAL NOTHING WAS BROKEN. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS DOING FINE POST-OPERATIVLELY. THERE WERE NO COMORBIDITIES FOR THE PATIENT. THE ORIGINAL DATE OF SURGERY WAS ON THE MONTH OF (B)(6) 2019. THIS REPORT IS FOR ONE (1) 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12116488 ↗
• 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), 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), TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX (PART NUMBER 04.004.000, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE. T

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

  MAUDE report 10108232 ↗
• InjuryDec 9, 2019Adverse 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 THE TITANIUM CANNULATED TIBIAL NAIL-EX THAT WAS IMPLANTED IN (B)(6) 2019. IT WAS NOTED THAT THE PATIENT WALKED RIGHT AFTER SURGERY AND ALLEGEDLY FELL AT AN ASSISTED LIVING FACILITY. THE HARDWARE HAD PENETRATED THE DISTAL TIBIA, HARDWARE WAS REMOVED AND THE PATIENT WAS PUT IN A CAST. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT STATUS AND PROCEDURE OUTCOMES ARE UNKNOWN. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 9439129 ↗
• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A SURGERY FOR INCISION AND DRAINAGE OF WOUND ON MEDIAL DISTAL TIBIA SLING WITH TIBIAL NAIL REMOVAL. THE DIAGNOSIS WAS AN INFECTED NON UNION OF THE TIBIA. THE HARDWARE CONSISTED OF ONE TIBIAL NAIL AND FOUR (4) 5.0 MM LOCKING SCREWS. ALL TIBIA HARDWARE WERE REMOVED SUCCESSFULLY. NONE OF THE HARDWARE WERE BROKEN. THE RETAINED REAMER PIECE THAT BROKE OFF DURING PRIOR SURGERY WAS ALSO REMOVED COMPLETELY. PATIENT WAS PLACED IN SPANNING EXTERNAL FIXATION AND WILL UNDERGO REVISION OPEN REDUCTION INTERNAL FIXATION (ORIF) AT A LATER DATE. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) TIBIAL NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8298253 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT HARDWARE REMOVAL, THE TITANIUM CANNULATED TIBIAL NAIL AND TWO (2) PROXIMAL SCREWS WERE REMOVED DUE TO PAINFUL HARDWARE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 10MM TI CANNULATED TIBIAL NAIL. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8261351 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REMOVAL OF TITANIUM CANNULATED TIBIAL NAIL DUE TO PAIN. ORIGINALLY, THE TIBIAL NAIL WAS IMPLANTED ON (B)(6) 2011 FOR A FRACTURED LEFT TIBIA. UNKNOWN SCREWS HAD BEEN REMOVED AT AN EARLIER DATE AT AN UNKNOWN FACILITY OUT OF STATE. THERE WAS NO INFORMATION ON THE REASON FOR INITIAL REMOVAL. THE FRACTURE HAD HEALED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT STATUS WAS STABLE. THIS REPORT IS FOR ONE (1) 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 8214364 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL OF ONE (1) TITANIUM CANNULATED TIBIAL NAIL WITH PROXIMAL BEND. FOLLOWING IMPLANTATION ON AN UNKNOWN DATE, THE PATIENT HAD GONE BACK FOR A FOLLOW-UP VISIT AND WAS DISCOVERED TO HAVE A MALUNION OF THE DISTAL TIBIA. THE MAL-UNION WAS CORRECTED WITH AN OSTEOTOMY AND ANOTHER TITANIUM CANNULATED TIBIAL NAIL WITH PROXIMAL BEND OF THE SAME SIZE WAS IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 7613640 ↗

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.