EZout 7812052001KRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327294538), received between Jan 5, 2018 and Jul 26, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJul 26, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397028 ↗
• MalfunctionAug 7, 2019Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT TWO BLADES BROKE IN THE SAME PROCEDURE, THIS RECORD REPRESENTS ONE OF THE BLADE BREAKAGES. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8869543 ↗
• MalfunctionAug 7, 2019Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT TWO BLADES BROKE IN THE SAME PROCEDURE, THIS RECORD REPRESENTS ONE OF THE BLADE BREAKAGES. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8869539 ↗
• MalfunctionMar 1, 2019Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BLADE BROKE IN HALF. IT WAS FURTHER REPORTED THAT THE BROKEN FRAGMENT WAS RETRIEVED AND THE BLADE WAS REPLACED. IT WAS ALSO REPORTED THAT THERE WERE NO MEDICAL INTERVENTION, NO DELAYS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8383128 ↗
• MalfunctionJun 28, 2018Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE BLADE BROKE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7645963 ↗
• MalfunctionJan 5, 2018Break; Break

  IT WAS REPORTED THAT DURING HIP SURGERY, THE BLADE BROKE. IT WAS FURTHER REPORTED THAT THE EVENT CAUSED A MINOR DELAY OF UNKNOWN DURATION. IT WAS ALSO REPORTED THAT ALL BLADE FRAGMENTS WERE RETRIEVED FROM THE PATIENT SUCCESSFULLY AND NO ADVERSE CONSEQUENCES OCCURRED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167179 ↗