SMART TSF 71075040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556746110), received between Feb 15, 2023 and May 28, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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

• InjuryMay 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TSF SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE SMART FX ID BANDS + CAPS (6+6) FELL OFF OR BROKE OFF OF A SMART FX STRUT MEDIUM DURING NORMAL PATIENT ACTIVITY OUTSIDE OF THE OR. SINCE THE SMART FX ID BAND WAS NO LONGER APPLIED TO THE STRUT, THE SMART FX STRUT COLLAPSED UNDER PHYSIOLOGIC LOAD AND REQUIRED A REVISION SURGERY ON (B)(6) 2024 TO CORRECT THIS FAILURE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 19407954 ↗
• MalfunctionApr 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A SMART TSF PROCEDURE, ONE (1) SMART FX ID BANDS + CAPS (6+6) BROKE CAUSING AN INADVERTENT CHANGE IN THE LENGTH OF A STRUT. THE DEVICE WAS REPLACED WITH A SMITH AND NEPHEW BACKUP DEVICE. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16746683 ↗
• MalfunctionFeb 15, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING TREATMENT WITH AN EXTERNAL FIXATOR, 3 SMART FX ID BANDS + CAPS (6+6), NUMBERS: 6 (VIOLET), 2 (ORANGE) AND ANOTHER (NUMBER UNKNOWN) FELL OFF THE SMART FX STRUTS ON PATIENT'S FRAME. ALSO A FOURTH BAND (NUMBER 1: RED) HAD BROKEN AND REMAINED HALF ON/HALF OFF. THE PATIENT IS IN EQUINUS FRAME, NON WEIGHT BEARING. IN ADDITION, ONE SMART FX STRUT LONG, WAS MISSING AN ID BAND AND HAD LOST IT'S LENGTH. IT WAS ASSUMED THAT THE WHITE BUTTON MUST HAVE BEEN PRESSED ACCIDENTALLY AND ENGAGED THE FAST FX MOVEMENT. THE PATIENT WAS NOT AWARE OF THE CAPABILITIES OF THIS BUTTON. HOWEVER, THE PATIENT COULD NOT READJUST THE STRUT TO IT'S ORIGINAL POSITION, IT HAD LOST ABOUT 8MM OF LENGTH. WHEN TRYING TO LENGTHEN, THE STRUT WOULD SLIP BACK AND SO IT WAS NOT POSSIBLE TO RESTORE THE LENGTH. PATIENT HAD MISSED MULTIPLE DAYS OF ADJUSTMENTS ON THIS STRUT AS A RESULT. ONCE THE NEW BAND WAS REPLACED ONTO THE STRUT, IT WAS ABLE TO BE ADJUSTED ONCE MORE. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380144 ↗