T2 1822-0931SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540197764), received between Sep 1, 2020 and Apr 15, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionApr 15, 2025Positioning Problem; Positioning Problem

  AS REPORTED: "T2 TIBIAL NAIL MOUNTED INCORRECTLY ON JIG AND IMPLANTED INCORRECTLY INTO PATIENT. NO REVISION SURGERY IS PLANNED AS FRACTURE HAS REDUCED AND HEALING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21838671 ↗
• MalfunctionJan 12, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED: "THE NAIL COULD NOT BE REMOVED AND REMAINED IN THE PATIENT'S BODY. A SURGICAL DELAY OF 30 MINUTES WAS REPORTED. UPDATE: THE PROCEDURE WAS A PLANNED REMOVAL DUE TO BONE HEALING. THE EVENT WAS NOT RESOLVED. THE NAIL COULD NOT BE REMOVED. AT THIS TIME, THE SURGEON DOES NOT PLAN TO MAKE ANOTHER ATTEMPT TO EXTRACT THE NAIL."

  Patient problems: Foreign Body In Patient

  MAUDE report 13235315 ↗
• InjurySep 1, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT TIBIA WAS REVISED DUE TO A BROKEN TIBIAL T2 NAIL AND NON-UNION. SURGEON REPORTED THAT THE PATIENT TRIED TO WEIGHT BEAR LESS THAN 2 MONTHS POST-OP.

  Patient problems: Failure of Implant; Injury; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10476965 ↗