DYONICS HELICUT 7205727Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010404664), received between Sep 29, 2017 and May 27, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Flaked” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HELICUT BLADE WAS LEAVING METAL DEBRIS. THE DEBRIS WAS REMOVED WITH SUCTION. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402200 ↗
• MalfunctionMay 27, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HELICUT BLADE WAS LEAVING METAL DEBRIS. THE DEBRIS WAS REMOVED WITH SUCTION. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402197 ↗
• InjuryOct 19, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE HELICUT BURR WAS SHEARING AND BREAKING OFF, LEAVING SMALL METAL FRAGMENTS IN THE JOINT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15634427 ↗
• InjurySep 6, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE HELICUT WAS ACTIVATED, METAL FLAKE WAS MADE IN THE PATIENT'S JOINT. IT IS UNKNOWN IF ALL THE PIECES WERE REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAY AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12431013 ↗
• MalfunctionMay 14, 2019Scratched Material

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY THE DOCTOR ASKED FOR THE HELICUT BLADE. IT WAS NOTICE THAT METALLIC PARTS WERE OBSERVED WHEN THE DEVICE STARTED TO BE USED IN THE OSTEOCHONDRAL LESION THAT THE PATIENT PRESENTED IN THE TALUS. NO PATIENT INJURIES REPORTED. NO DELAY WAS REPORTED. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8608975 ↗
• MalfunctionDec 12, 2018Material Fragmentation

  IT WAS REPORTED THAT, DURING A PROCEDURE, METAL FLAKES WERE SHED WHEN TRYING TO RESECT AN OSTEOPHYTE (BONE SPUR). IT IS UNKNOWN WHETHER THERE WAS A BACK-UP DEVICE AVAILABLE TO COMPLETE THE INTENDED PROCEDURE. EVEN THOUGH IT REMAINS UNKNOWN IF THE FLAKES WERE REMOVED FROM THE PATIENT, IT WAS STATED THAT NEITHER PATIENT INJURIES/COMPLICATIONS NOR DELAY SURGICAL TIME HAPPENED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8158088 ↗
• MalfunctionMar 1, 2018Metal Shedding Debris

  IT WAS REPORTED THAT SURGEON STATED THE HELICUT BURR SHED METAL MORE THAN USUAL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7307836 ↗
• MalfunctionSep 29, 2017Metal Shedding Debris

  IT WAS REPORTED THAT THE HELICUT BURR WAS SHEDDING AND SOME DEBRIS BECAME STUCK IN THE TISSUE. NO DELAY OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6905435 ↗