EXPert Nail 04.034.552SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982095381), received between May 25, 2018 and Nov 11, 2022 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, A EXPERT TN Ø11 W/PROX-BEND CANN L360 TAN AND AN UNKNOWN SCREW WERE REMOVED FROM A PATIENT BECAUSE OF A POSSIBLE INFECTION. EXPERT TN Ø11 W/PROX-BEND CANN L360 TAN WERE TREATED WITH ANTIBIOTIC. THE HARDWARE CAME OUT SUCCESSFULLY. THERE WAS PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 11 TI CANN TIB NAIL-EX PROX BEND 360-S. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15778291 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, A EXPERT TN Ø11 W/PROX-BEND CANN L360 TAN AND AN UNKNOWN SCREW WERE REMOVED FROM A PATIENT BECAUSE OF A POSSIBLE INFECTION. EXPERT TN Ø11 W/PROX-BEND CANN L360 TAN WERE TREATED WITH ANTIBIOTIC. THE HARDWARE CAME OUT SUCCESSFULLY. THERE WAS PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 11 TI CANN TIB NAIL-EX PROX BEND 360-S. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15771657 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE A TIBIAL NAIL AND SCREWS WERE REMOVED FROM A PATIENT BECAUSE OF A POSSIBLE INFECTION. THE HARDWARE CAME OUT SUCCESSFULLY AND NAIL WAS IMPLANTED AT (B)(6) IN (B)(6) OF 2021. THIS REPORT IS FOR ONE (1) 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 12700389 ↗
• InjuryMar 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT IMPLANT PROCEDURE. ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO INFECTION. DEVICES REMOVED WERE ONE (1) STERILE TITANIUM CANNULATED TIBIAL NAIL, ONE (1) 5MM DUAL CORE LOCKING SCREW, AND AN UNKNOWN QUANTITY OF 5MM LOCKING SCREWS. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS IS OKAY. THIS REPORT IS FOR ONE (1) TIBIAL NAIL. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8445239 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018, TO REMOVE FIVE (5) TITANIUM LOCKING SCREWS, AN 11MM TITANIUM CANNULATED TIBIAL NAIL AND A TITANIUM END CAP DUE TO DELAYED HEALING AND A NON-UNION. THE ORIGINAL IMPLANT DATE OF THE EXPLANTED DEVICES IS UNKNOWN AT THIS TIME. THE PATIENT WAS REVISED TO A LARGER 13MM TIBIAL NAIL AND USED A LOCKING SCREW ON THE LATERAL SIDE TO AID WITH PROPER REDUCTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAYS AND NO ADDITIONAL MEDICAL INTERVENTION REQUIRED DURING THE PROCEDURE. NO PATIENT OUTCOME REPORTED. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7546002 ↗

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.