NA 72200725Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010578037), received between Jun 30, 2021 and Apr 27, 2026 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A SURGERY, THERE WERE FLECKS OF METAL COMING OFF THE ACROMIONIZER INTO THE PATIENT. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT SN BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. THE PIECES WERE REMOVED USING SUCTION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010221 ↗
• MalfunctionAug 3, 2023Melted; Noise, Audible; Melted; Noise, Audible

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DYONICS BURR MADE A STRANGE NOISE WHEN IT OPERATED, AND THE TIP OF THE BURR MELTED. THE PROCEDURE WAS COMPLETED WITH DELAY GREATER THAN 30 MINUTE USING A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455628 ↗
• InjuryJun 30, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE THE PATIENT IN AN ARTHROSCOPY, THE BLADE SHREDDED OFF, THEY MANAGED TO REMOVE THE DEBRIS BUT THE INNER BLADES SEEMED TO BECOME STUCK AND THEREFORE WAS UNABLE TO ROTATE. ALL REMAINING MATERIAL WAS REMOVED FROM SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096013 ↗