SMART TSF 71075730Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556745649), received between Nov 20, 2024 and Jul 10, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Collapse” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Collapse; Collapse

  IT WAS REPORTED THAT AFTER AN EXTERNAL FIXATION SURGERY PERFORMED ON (B)(6) 2025, ONE (1) SMART FX STRUT LONG COLLAPSED UNDER LOAD. THIS ISSUE WAS SOLVED THE SAME DAY ((B)(6) 2025) BY REPLACING THE SMART FX STRUT MEDIUM WITH A S+N DEVICE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472998 ↗
• MalfunctionNov 20, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING AN EXTERNAL FIXATION, SIX (X6) SMART FX STRUT LONG WERE BEING USED FOR A TRAUMA FRAME WHERE THE RINGS WERE MOUNTED AND THEN AN ON THE TABLE REDUCTION WAS PERFORMED. DUE TO A DIFFICULT FRACTURE PATTERN, THE REDUCTION HAD TO BE REPEATED MULTIPLE TIMES TO ACHIEVE GOOD ALIGNMENT. HAVING TO USE THE WHITE CLIPS TO LOCK/UNLOCK THE STRUTS TOOK A CONSIDERABLE AMOUNT OF TIME AND MADE THE OPERATION MORE DIFFICULT FOR THE SURGEON. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. AFTER A SIGNIFICANT DELAY . NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733196 ↗