NA 72205110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556708910), received between Feb 12, 2024 and Feb 12, 2024 — classified as 1 malfunction.

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

• MalfunctionFeb 12, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE SURGEON NOTICED A LOOSE METAL FLECK ON THE SIDE OF THE SYNOVATOR PLATINUM BLADE. THE BLADE WAS PULLED OUT FROM THE KNEE JOINT AND THE METAL FLECK WAS WIPED OFF. NO PIECE FELL INSIDE THE JOINT, SINCE THE SURGEON NOTICED THE PROBLEM IN TIME. THE PROCEDURE WAS COMPLETED USING THE SAME REPORTED DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18692175 ↗