ACF 396.409Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034777610), received between Dec 7, 2020 and Dec 7, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT 9 MILLIMETER ACF TRIAL SPACER WAS LOCATED IN MDRD AND FLAGGED AS BROKEN. IT IS NOT KNOWN HOW OR WHEN IT BECAME BROKEN. THE PLASTIC HANDLE IS CRACKED AND LOOSE. NO PIECES APPEAR TO BE MISSING. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) ACF TRIAL SPACER/PARALLEL 9MM. . THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10960993 ↗