NA 03.211.116Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982076212), received between Aug 11, 2023 and Sep 9, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE CUP AND CONE REAMERS WERE NO LONGER SHARP FOR MTP FUSION JOINT PREP.

  Patient problems: Insufficient Information

  MAUDE report 23006139 ↗
• MalfunctionAug 11, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BLUNT THROUGH GENERAL WEAR AND TEAR. THIS REPORT INVOLVES ONE (1) CANNULATED REAMER PROXIMAL/16MM. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17509539 ↗
• MalfunctionAug 11, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BLUNT THROUGH GENERAL WEAR AND TEAR. THIS REPORT INVOLVES ONE (1) CANNULATED REAMER PROXIMAL/16MM. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17509238 ↗