EXPert Nail 04.034.558SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982095404), received between Jul 23, 2018 and May 31, 2021 — classified as 2 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 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 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A TIBIA NAIL HARDWARE REMOVAL DUE TO NON-UNION WITH EXCHANGE NAILING REMOVAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR 1 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 390MM-STERILE. THIS IS REPORT 1 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11907570 ↗
• InjuryDec 10, 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 A HARDWARE REMOVAL OF ONE (1) TIBIAL NAIL AND FOUR (4) LOCKING SCREWS. A REAMER IRRIGATOR ASPIRATOR (RIA) WAS DONE DUE TO POSSIBLE INFECTION. IT APPEARED THAT THE FRACTURE WAS HEALED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 390MM-STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9445024 ↗
• MalfunctionJul 23, 2018Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE PROCEDURE, THE CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE GOT JAMMED IN THE TIBIAL NAIL. THE CONNECTING SCREW WAS UNABLE TO LOOSEN FROM THE TIBIAL NAIL, REQUIRING A NEW TIBIAL NAIL AND CONNECTING SCREW. IT WAS UNCLEAR IF THE CONNECTING SCREW HAD STRIPPED. AFTER THE SURGERY WAS OVER, THE CONNECTING BOLT WAS SUCCESSFULLY DISCONNECTED FROM THE NAIL AFTER SEVERAL ATTEMPTS. NO PATIENT CONSEQUENCE WAS REPORTED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS NOT UNKNOWN. THIS REPORT IS FOR ONE (1) 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 390MM-STERILE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7710570 ↗

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.