EXPert Nail 04.034.443SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982095220), received between May 18, 2018 and Dec 2, 2022 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT HAD NON-UNION, MAL-UNION TIBIA NAIL AND REVISION SURGERY. 1 EX TIBIA NAIL 10X315MM, 4 SCREW 5.0 MM, 1 SCREW 5.0 MM WAS REMOVED. NO ADDITIONAL INFORMATION WAS REPORTED. THIS REPORT IS FOR ONE (1) 10 TI CANN TIB NAIL-EX PROX BEND 315-S. THIS IS REPORT 1 OF 6 FOR COMPLAINT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15905203 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A TIBIAL NAIL WAS REMOVED DUE TO INFECTION AND NON-UNION. AN EXTERNAL FIXATOR WILL BE PLACED BECAUSE OF A POSSIBLE INFECTION. THE PATIENT DID NOT EXPERIENCE A POST-OP DEVICE MALFUNCTION. THIS NAIL WAS ORIGINALLY IMPLANTED IN (B)(6) 2021. DURING THE REAMING PROCESS, DURING THE REVISION, THEY ATTEMPTED TO BEND THE TIP OF A 2.5 REAMING ROD AND THE TIP BROKE OFF. ANOTHER REAMING ROD WAS OPENED, AND SURGERY WAS SUCCESSFULLY COMPLETED. THIS (B)(4) WILL CAPTURE THE POST OP EVENT WHERE THERE WAS A DEVICE REMOVAL DUE TO INFECTION. WHILE (B)(4) WAS CREATED TO CAPTURE THE INTRA OP EVENT IN WHICH DURING THE SURGERY THE TIP OF A 2.5 REAMING ROD AND THE TIP BROKE OFF. THIS IS REPORT 1 OF 7 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN TIBIAL NAIL.

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

  MAUDE report 14456876 ↗
• InjuryDec 13, 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 TIBIAL FRACTURE SURGERY WITH THE IMPLANTS IN QUESTION. POSTOPERATIVELY, THE PATIENT EXPERIENCED MALUNION. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 315MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 12985136 ↗
• InjuryMay 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF A TIBIAL NAIL AND FOUR (4) UNKNOWN LOCKING SCREWS ON (B)(6) 2018, DUE TO INFECTION. ALL HARDWARE WAS REMOVED INTACT. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS REPORTED AS SUCCESSFUL, THE FRACTURE HAD HEALED. THE HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2017. AFTER THE INITIAL SURGERY, THE PATIENT COMPLAINED ABOUT THE INTERLOCKING SCREW AND THEN ON A POST-OPERATIVE EXAM, INFECTION WAS IDENTIFIED AROUND THE NAIL AT THE SECOND DISTAL LOCKING SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7526669 ↗

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.