NA 72200729Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010578075), received between Oct 3, 2019 and Sep 5, 2021 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Melted” (6 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.

• InjurySep 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿ARTHROSCOPIC LATERAL PATELLAR FACETECTOMY AND LATERAL RELEASE CAN BE RECOMMENDED FOR ISOLATED PATELLOFEMORAL OSTEOARTHRITIS. ¿, AFTER SURGERY WITH A DYONICS 5.5 MM ELITE STONECUTTER BURR ONE PATIENT HAD RECURRENCE SYMPTOMS REQUIRING REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12426604 ↗
• InjurySep 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿ARTHROSCOPIC LATERAL PATELLAR FACETECTOMY AND LATERAL RELEASE CAN BE RECOMMENDED FOR ISOLATED PATELLOFEMORAL OSTEOARTHRITIS. ¿, AFTER SURGERY WITH A DYONICS 5.5 MM ELITE STONECUTTER BURR, SIX PATIENTS HAD REVISION SURGERY REQUIRING A TOTAL KNEE REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12426603 ↗
• InjurySep 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿ARTHROSCOPIC LATERAL PATELLAR FACETECTOMY AND LATERAL RELEASE CAN BE RECOMMENDED FOR ISOLATED PATELLOFEMORAL OSTEOARTHRITIS. ¿, AFTER SURGERY WITH A DYONICS 5.5 MM ELITE STONECUTTER BURR TWO PATIENTS HAD REVISION SURGERY REQUIRING HIGH VALGUS OSTEOTOMY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12426602 ↗
• MalfunctionOct 3, 2019Melted; Overheating of Device; Noise, Audible; Melted; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE DEVICE WAS NOISY DURING USE. A TEST WAS PERFORMED: CHANGE OF HANDPIECE AND OF THE CONSOLE, BUT NO SIGNIFICANT IMPROVEMENT WAS SHOWN. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES. RESULTS OF THE INVESTIGATION HAVE CONCLUDED THAT THIS UNIT SHOWED SYMPTOMS OF EXCESS HEAT GENERATED AND OVERHEATING WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9153109 ↗
• MalfunctionOct 3, 2019Melted; Overheating of Device; Noise, Audible; Melted; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE DEVICE WAS NOISY DURING USE. A TEST WAS PERFORMED: CHANGE OF HANDPIECE AND OF THE CONSOLE, BUT NO SIGNIFICANT IMPROVEMENT WAS SHOWN. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES. RESULTS OF THE INVESTIGATION HAVE CONCLUDED THAT THIS UNIT SHOWED SYMPTOMS OF EXCESS HEAT GENERATED AND OVERHEATING WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9153081 ↗
• MalfunctionOct 3, 2019Melted; Overheating of Device; Noise, Audible; Melted; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE DEVICE WAS NOISY DURING USE. A TEST WAS PERFORMED: CHANGE OF HANDPIECE AND OF THE CONSOLE, BUT NO SIGNIFICANT IMPROVEMENT WAS SHOWN. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES. RESULTS OF THE INVESTIGATION HAVE CONCLUDED THAT THIS UNIT SHOWED SYMPTOMS OF EXCESS HEAT GENERATED AND OVERHEATING WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9153067 ↗
• MalfunctionOct 3, 2019Melted; Overheating of Device; Noise, Audible; Melted; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE DEVICE WAS NOISY DURING USE. A TEST WAS PERFORMED: CHANGE OF HANDPIECE AND OF THE CONSOLE, BUT NO SIGNIFICANT IMPROVEMENT WAS SHOWN. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES. RESULTS OF THE INVESTIGATION HAVE CONCLUDED THAT THIS UNIT SHOWED SYMPTOMS OF EXCESS HEAT GENERATED AND OVERHEATING WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9153026 ↗
• MalfunctionOct 3, 2019Melted; Overheating of Device; Noise, Audible; Melted; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE DEVICE WAS NOISY DURING USE. A TEST WAS PERFORMED: CHANGE OF HANDPIECE AND OF THE CONSOLE, BUT NO SIGNIFICANT IMPROVEMENT WAS SHOWN. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES. RESULTS OF THE INVESTIGATION HAVE CONCLUDED THAT THIS UNIT SHOWED SYMPTOMS OF EXCESS HEAT GENERATED AND OVERHEATING WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9153005 ↗
• MalfunctionOct 3, 2019Melted; Overheating of Device; Noise, Audible; Melted; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE DEVICE WAS NOISY DURING USE. A TEST WAS PERFORMED: CHANGE OF HANDPIECE AND OF THE CONSOLE, BUT NO SIGNIFICANT IMPROVEMENT WAS SHOWN. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES. RESULTS OF THE INVESTIGATION HAVE CONCLUDED THAT THIS UNIT SHOWED SYMPTOMS OF EXCESS HEAT GENERATED AND OVERHEATING WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9153000 ↗