DYONICS 72203127Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010655899), received between Aug 25, 2017 and Apr 19, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Metal Shedding Debris” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2026Flaked; Melted

  IT WAS REPORTED THAT, DURING RESECTION OF THE ACETABULAR RIM IN A HIP ARTHROSCOPIC PROCEDURE, THE ABRADER BURR CEASED TO WORK AND UPON REMOVAL FROM THE HANDPIECE, THE HUB OF THE BURR WAS MELTED. THE HANDPIECE WAS NOT AFFECTED. AN INTERVENTION WAS REQUIRED TO REMOVE BLUE PARTICULATE DEBRIS FROM THE JOINT. THE PROCEDURE WAS RESUMED, WITH A 2 MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921352 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT, DURING A LEFT HIP ARTHROSCOPY, A DYONICS ABRADER BURR BROKE INSIDE THE PATIENT; THE PROBLEM SEEMED TO COME FROM THE BLUE PLASTIC PORTION AT THE BASE OF THE BURR, WHICH CONNECTED TO THE HANDPIECE. THERE WAS BLUE PLASTIC FRAGMENTS WERE FOUND INSIDE THE PATIENT; THE FRAGMENTS WERE CLEANED FROM THE PATIENT USING A SHAVER AND SUCTION. THE PROCEDURE WAS RESUMED, WITH A DELAY OF 10 MINUTES, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750594 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, A DYONICS ABRADER BURR BROKE INSIDE THE PATIENT; THE PROBLEM SEEMED TO COME FROM THE BLUE PLASTIC PORTION AT THE BASE OF THE BURRS, WHICH CONNECTED TO THE HANDPIECE. THERE WAS BLUE PLASTIC FRAGMENTS WERE FOUND INSIDE THE PATIENT; THE FRAGMENTS WERE CLEANED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A DELAY OF 10 MINUTES, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700959 ↗
• MalfunctionApr 15, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS A HAIR IN THE HUB OF THE ABRADER BURR. INCIDENT OCCURRED WHILE SETTING-UP TO A HIP PROCEDURE. A BACK-UP DEVICE WAS AVAILABLE AND NO SIGNIFICANT DELAYS OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11676274 ↗
• InjuryJul 12, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BLUE PLASTIC PART IN THE DISTAL PART OF THE BURR 5.5 ABRADER SEEMS WORN OUT BY THE ROTATION OF THE STEM IN THE PART OF THE GRAFT, LEAVING BLUE WHIPS IN THE JOINT AND ON A GAUZE. IT IS UNKNOWN WHETHER THERE WAS A BACK UP AVAILABLE OR DELAY IN THE CASE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10262223 ↗
• InjuryJul 12, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BLUE PLASTIC PART IN THE DISTAL PART OF THE BURR 5.5 ABRADER SEEMS WORN OUT BY THE ROTATION OF THE STEM IN THE PART OF THE GRAFT, LEAVING BLUE WHIPS IN THE JOINT AND ON A GAUZE. IT IS UNKNOWN WHETHER THERE WAS A BACK UP AVAILABLE OR DELAY IN THE CASE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10262222 ↗
• MalfunctionMay 31, 2018Detachment Of Device Component; Component Falling; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SURGEON WAS USING BURR TO DEBRIDE BONE IN HIP WHEN HE NOTED A SMALL FLECK OF BLUE PLASTIC FELL OFF THE BURR. THE FLECK WAS REMOVED VIA SUCTION AND NOT OTHER DEBRIS WAS NOTED. THE BURR FUNCTIONED AS EXPECTED WITH NO FURTHER INCIDENT. NO SIGNIFICANT PROCEDURAL DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7556646 ↗
• MalfunctionApr 20, 2018Metal Shedding Debris

  IT WAS REPORTED THAT THE DEVICE HAS METAL SHAVING FROM BURR. PROCEDURE WAS COMPLETED WITH A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7446023 ↗
• MalfunctionDec 11, 2017Metal Shedding Debris

  IT WAS REPORTED THAT THE SURGEON NOTICED METAL SHREDS COMING OFF BURR WHILE PERFORMING A HIP ARTHROSCOPY. SURGEON MADE ALL EFFORT TO REMOVE AS MUCH SHEDDINGS. SURGEON TRIED TO REMOVE ALL METAL SHREDS/PARTICLES OUT OF PATIENT'S HIP. SUCTION AND FLUSHING PERFORMED, SOME METAL PARTICLES WERE NOT REMOVED AS STUCK IN GOOD/HEALTHY TISSUE EVEN IF FLUSHING AND SUCTION PERFORMED. ANOTHER BURR WAS OPENED FOR USE AND PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7104094 ↗
• MalfunctionAug 31, 2017Metal Shedding Debris

  IT WAS REPORTED THAT THE BURRS WERE CAUSING METAL FLAKING DURING THE PROCEDURE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT IMPACT. THERE WAS A SHORT DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6836625 ↗
• MalfunctionAug 31, 2017Metal Shedding Debris

  IT WAS REPORTED THAT THE BURRS WERE CAUSING METAL FLAKING DURING THE PROCEDURE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT IMPACT. THERE WAS A SHORT DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6836622 ↗
• MalfunctionAug 31, 2017Metal Shedding Debris

  IT WAS REPORTED THAT THE BURRS WERE CAUSING METAL FLAKING DURING THE PROCEDURE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT IMPACT. THERE WAS A SHORT DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6836349 ↗
• MalfunctionAug 25, 2017Metal Shedding Debris

  IT WAS REPORTED THAT PIECES OF METAL FROM THE BURR WERE COMING OFF AND LEAVING TINY SHARDS IN THE PATIENT. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6821170 ↗
• MalfunctionAug 25, 2017Metal Shedding Debris

  IT WAS REPORTED THAT PIECES OF METAL FROM THE BURR WERE COMING OFF AND LEAVING TINY SHARDS IN THE PATIENT. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6821167 ↗