NA 72200728Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010578068), received between Nov 16, 2018 and May 9, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING A PROCEDURE, ONE OF THE DYONICS BURR PRODUCT COLLAR SHREDDED WHEN PUT ON MAXIMUM POWER. THE PROCEDURE WAS COMPLETED WITHOUT THE PRODUCT AND AN UNKNOWN AMOUNT OF TIME OF SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994158 ↗
• MalfunctionMay 20, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY, THE TIP OF THE DYONICS STONECUTTER FELL OFF. METAL SHAVINGS WERE NOTED IN THE PATIENT VIA ARTHROSCOPE. ALL METAL SHAVINGS WERE SUCTIONED OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351930 ↗
• MalfunctionMay 23, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DISTAL CLAVICLE EXCISION, THE DYONICS STONECUTTER BURR SHREDDED A BIT AND CREATED SOME METAL SHAVINGS IN THE SHOULDER. ALL THE METAL SHAVINGS WERE CLEANED UP WITH A SHAVER. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988868 ↗
• MalfunctionOct 22, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADE MADE NOISE WHEN THE DEVICE IS ROTATING. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. RESULTS OF THE INVESTIGATION HAVE CONCLUDED THAT THIS UNIT OVERHEATED WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9218863 ↗
• MalfunctionJun 19, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER CONNECTING THE BURR ON THE HANDPIECE, THE BURR STOPPED TURNING AND THE HANDPIECE SETS TO ALARM STATE. REMOVING THE BURR, PLASTICS HAD BEEN DAMAGED. THE SURGEON CHANGED THE HANDPIECE AND THE INCIDENT REPEATED AGAIN. THEN THE SURGEON USED ANOTHER BURR (OTHER PRODUCT REFERENCE WITH BIGGER DIAMETER AND IT WAS OK.) NO PLASTICS PIECES WERE LEFT INTO THE PATIENT. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8714163 ↗
• MalfunctionJun 18, 2019Material Separation; Material Separation; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER CONNECTING THE BURR ON THE HANDPIECE, THE BURR STOPPED TURNING AND THE HANDPIECE SETS TO ALARM STATE. REMOVING THE BURR, PLASTICS HAD BEEN DAMAGED. THE SURGEON CHANGED THE HANDPIECE AND THE INCIDENT REPEATED AGAIN. THEN THE SURGEON USED ANOTHER BURR (OTHER PRODUCT REFERENCE WITH BIGGER DIAMETER AND IT WAS OK.) NO PLASTICS PIECES WERE LEFT INTO THE PATIENT. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8709609 ↗
• MalfunctionDec 4, 2018Melted; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE BLADE MADE A NOISE WHEN THE DEVICE IS ROTATING. NO PATIENT INJURY REPORTED. BACK-UP DEVICE WAS USED TO COMPLETE THE SURGERY. ACCORDING TO INVESTIGATION RESULTS, THE PRODUCT HAS BECOME OVER HEATED AND THE SLUFF CHAMBER AND ADAPTER BODY HAVE BEGUN TO MELT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8129876 ↗
• MalfunctionNov 16, 2018Overheating of Device; Temperature Problem

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8080917 ↗
• MalfunctionNov 16, 2018Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8080874 ↗