NA 04.005.546SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982086150), received between Jul 25, 2018 and May 15, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PROXIMAL PORTION OF THE TFNA NAIL WAS BROKEN. THE IMPLANTS HAD BEEN IMPLANTED ABOUT THREE MONTHS AGO. THE TFNA IMPLANTS WERE EXTRACTED, AND THE RIA 2 WAS USED TO GATHER CULTURES. THE TFNA WAS REPLACED WITH A 10X420 RIGHT TFN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 5.0 TI LCKNG SCREW T25 SD 56 F/IM NAIL-S. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16935753 ↗
• InjuryJul 7, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE REMOVAL OF BROKEN NAIL DUE TO NONUNION. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO FRAGMENTS WERE GENERATED. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (15.0 TI LCKNG SCREW T25 SD 56 F/IM NAIL-S. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14950315 ↗
• InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT IMPLANT PROCEDURE. PATIENT WAS IMPLANTED WITH ONE (1) UNKNOWN NAIL, ONE 1) 5MM TITANIUM LOCKING SCREW 42MM AND ONE (1) 5MM TITANIUM LOCKING SCREW 56MM. POST-OPERATIVE ON (B)(6) 2018, PATIENT UNDERWENT ROTATIONAL OSTEOTOMY OF THE FEMUR DUE TO BONE NOT HAVING HEALED AND THE ALIGNMENT BEING OFF. DURING THE SURGERY, SURGEON REMOVED TWO SCREWS AND IMPLANTED TWO NEW SCREWS BACK IN THE NAIL. THE SCREWS WERE REMOVED INTACT, WITHOUT DIFFICULTY, THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 56MM F/IM NAIL-STER THIS IS REPORT 3 OF 3 FOR (B)(4).

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

  MAUDE report 7719678 ↗