AUTOFIX 141-2522Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700586900936), received between Dec 2, 2019 and Dec 2, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 18, 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.

• MalfunctionDec 2, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ORDER THAT : "FOR THE 2 SCREWS THAT FAILED TO BE INSTALLED, A DECLARATION OF MATERIAL VIGILANCE WAS MADE TO THE ANSM" IT'S ALSO REPORTED THAT THE SCREWDRIVER IS BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9398378 ↗
• MalfunctionDec 2, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ORDER THAT : "FOR THE 2 SCREWS THAT FAILED TO BE INSTALLED, A DECLARATION OF MATERIAL VIGILANCE WAS MADE TO THE ANSM" IT'S ALSO REPORTED THAT THE SCREWDRIVER IS BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9398372 ↗