NA 72200723Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010578013), received between Aug 23, 2017 and Aug 7, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Flaked” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A PROCEDURE THE DYONICS ABRADER BURR HAD EXCESSIVE METAL FLAKING. THE FLAKED VISIBLE MATERIAL WAS RETRIEVED FROM THE PATIENT WITH SUCTION. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927965 ↗
• InjuryAug 24, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING SURGERY THE DYONICS 5.5MM ELITE ABRADER BURR WAS SHOWING METAL DEBRIS IN THE JOINT AND RUBBING ON THE INSIDE SHAFT OF THE BLADE; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10445588 ↗
• InjuryAug 24, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING SURGERY THE DYONICS 5.5MM ELITE ABRADER BURR WAS SHOWING METAL DEBRIS IN THE JOINT AND RUBBING ON THE INSIDE SHAFT OF THE BLADE; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10445528 ↗
• MalfunctionAug 23, 2017Metal Shedding Debris

  IT WAS REPORTED THAT METAL SHAVINGS CAME OFF THE BURR. ALL PIECES WERE REMOVED FROM THE PATIENT. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6813063 ↗