SMART TSF 71074530Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556745953), received between Dec 19, 2024 and Dec 19, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A EXTENDED HA PIN 4.5MM 30MM X 150MM WAS INSERTED AND CHECKED ON XRAY. IT WAS DECIDED THE PIN WAS INSERTED TOO FAR SO THE SURGEON ATTEMPTED TO BACK IT OUT SLIGHTLY. THE PIN SHEARED OFF. A NON-SIGNIFICANT DELAY WAS REPORTED. THE PATIENT'S HEALTH STATUS OR HOW THE PROCEDURE WAS FINISHED IS STILL UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20977178 ↗