Maestro 5400210257Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540469267), received between Jul 24, 2018 and Apr 6, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2023Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE TIP BROKEN DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16695083 ↗
• MalfunctionDec 17, 2020Material Twisted/Bent; Material Twisted/Bent

  THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE DEVICE HAD A BENT FOOT WHILE IT WAS BEING DEMONSTRATED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11032052 ↗
• MalfunctionJun 29, 2020Material Twisted/Bent; Material Twisted/Bent

  THE USER FACILITY REPORTED THAT THE DEVICE HAD A BENT FOOT DURING INSTALLATION PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10208459 ↗
• MalfunctionJun 18, 2019Break; Break

  THE USER FACILITY REPORTED THAT THE BLADE SHEATH BROKE OFF DURING A PROCEDURE. THE BROKEN COMPONENT DURING A PROCEDURE COULD RESULT IN DAMAGE TO THE DURA REQUIRING MEDICAL INTERVINTION. THERE WAS NO PATIENT IMPACT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT; NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8709755 ↗
• MalfunctionDec 12, 2018Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE DEVICE WAS BROKEN DURING A PROCEDURE. UPON INSPECTION AT THE MANUFACTURER, THE TECHNICIAN NOTED THAT THE DEVICE HAD A FRACTURED FOOT. THERE WAS NO PATIENT IMPACT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8157114 ↗
• MalfunctionJul 24, 2018Material Twisted/Bent; Material Twisted/Bent

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS BENT. ONE EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 7714940 ↗