NA 7205311Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010251398), received between Sep 21, 2018 and Sep 11, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Disintegration” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING SET UP, WHEN THE NEW BOX OF SYNOVATOR BLADES WAS OPENED, ONE OF THE OUTER PACKAGES WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190422 ↗
• MalfunctionSep 21, 2018Material Disintegration

  IT WAS REPORTED THAT TINY SPECS OF METAL DID GRIND OUT OF THE DEVICE INTO THE JOINT. NO PATIENT INJURY OR SIGNIFICANT DELAY WERE REPORTED. A BACK UP WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7898989 ↗