NA 7210751Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010532596), received between Jun 23, 2018 and Sep 27, 2021 — classified as 1 injury, 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. 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.

• InjurySep 27, 2021Flaked; Flaked

  IT WAS REPORTED THAT, DURING ARTHROSCOPY, A BLADE 3.5MM ELITE FULL RADIUS CREATED METAL FLAKE. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY (LESS OR EQUAL TO 30MIN), WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533731 ↗
• MalfunctionJun 23, 2018Material Fragmentation

  IT WAS REPORTED THAT SOME SMALL METAL FRAGMENTS WERE NUDGED OFF THE TOP INNER PART OF THE SHAVER BLADE. IT IS UNKNOWN IF ALL THE PIECES WERE REMOVED FROM THE PATIENT, HOWEVER, THIS DOES NOT REPRESENT ANY SERIOUS INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7632574 ↗