NA 72200616SRecalls & reported problems

Summary

The FDA's MAUDE database contains 486 adverse event reports that list this exact device (DI 03596010565105), received between Mar 30, 2017 and Jun 14, 2026 — classified as 1 injury, 485 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (249 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 25 most recent of 486 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2026Overheating of Device

  IT WAS REPORTED THAT THE MDU GOT WARM. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25497585 ↗
• MalfunctionMay 1, 2026Mechanical Problem; Overheating of Device

  IT WAS REPORTED THAT, BEFORE A SURGERY, IT WAS NOTICED THAT THE MDU WAS OVERHEATING. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062251 ↗
• MalfunctionApr 18, 2026Overheating of Device

  IT WAS REPORTED THAT A SVC REPL, MDU, HAND CNTRL, PWRMX WAS OVERHEATING. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919869 ↗
• MalfunctionMar 12, 2026Overheating of Device

  IT WAS REPORTED THAT THE MDU SHAVER WAS OVERHEATING. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY, IF THERE WAS PATIENT INVOLVEMENT, IF THERE WAS A BACK-UP DEVICE AVAILABLE, OR IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586125 ↗
• MalfunctionMar 5, 2026Overheating of Device

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC KNEE PROCEDURE, A MOTOR DRIVE UNIT WAS GETTING HOT TO TOUCH. THE SURGEON STOPPED USING IT AS SOON AS THEY FELT THE HEAT INCREASING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24526656 ↗
• MalfunctionMar 2, 2026Overheating of Device

  IT WAS REPORTED THAT A SVC REPL, MDU, HAND CNTRL, PWRMX WAS OVERHEATING. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480056 ↗
• MalfunctionMar 2, 2026Overheating of Device

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, A MOTOR DRIVE UNIT WAS OVERHEATING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480024 ↗
• MalfunctionFeb 25, 2026Overheating of Device

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, A DYONICS POWERMAX HANDPIECE WAS OVERHEATING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. THERE ARE NO CONCERNS REGARDING THE PATIENT'S HEALTH STATUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24446598 ↗
• MalfunctionFeb 14, 2026Overheating of Device

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, IT WAS NOTICED THAT THE MDU WAS OVERHEATING. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. NO HARM, BURN OR NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341323 ↗
• MalfunctionFeb 2, 2026Overheating of Device

  IT WAS REPORTED THAT, DURING SURGERY, ONE (1) MDU POWERMAX WAS OVERHEATING (MAINLY THE CABLE). IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND HOW THE PROCEDURE WAS FINISHED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236430 ↗
• MalfunctionJan 16, 2026Overheating of Device; Mechanical Jam; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE MDU OVERHEATED AND STOPPED WORKING. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093246 ↗
• MalfunctionJan 15, 2026Overheating of Device; Electrical Shorting; Mechanical Jam

  IT WAS REPORTED THAT THE MDU OVERHEATED AND HAD A SHORT CIRCUIT ERROR ON THE CONSOLE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24090594 ↗
• MalfunctionJan 14, 2026Overheating of Device; Mechanical Jam; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE MDU DID NOT WORK AND THE CABLE GOT HOT. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068090 ↗
• MalfunctionJan 14, 2026Overheating of Device; Electrical Shorting

  IT WAS REPORTED THAT THE MDU OVERHEATED AND HAD A SHORT CIRCUIT ERROR ON THE CONSOLE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067994 ↗
• MalfunctionJan 13, 2026Overheating of Device; Electrical Shorting; Mechanical Jam

  IT WAS REPORTED THAT MDU OVERHEATED AND THREW A SHORT CIRCUIT ERROR ON THE CONSOLE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053475 ↗
• MalfunctionDec 26, 2025Failure to Shut Off; Intermittent Energy Output; Failure to Shut Off; Intermittent Energy Output

  IT WAS REPORTED THAT, AFTER KNEE ARTHROSCOPY, AN MDU CONTINUED TO OSCILLATE WHEN SWITCHED OFF, AND TURNED OFF WHEN IN USE. SINCE INCIDENT OCCURRED AFTER PROCEDURE; PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23899556 ↗
• MalfunctionDec 24, 2025Overheating of Device; Insufficient Device Problem Information; Overheating of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A SURGERY, A MOTOR DRIVE UNIT WAS OVERHEATING, AND STOPPED WORKING. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888771 ↗
• MalfunctionNov 27, 2025Overheating of Device; Material Twisted/Bent; Overheating of Device; Material Twisted/Bent

  IT WAS REPORTED THAT THE MDU WAS OVERHEATING. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23666168 ↗
• MalfunctionNov 26, 2025Device Alarm System; Mechanical Problem; Overheating of Device; Device Alarm System; Mechanical Problem; Overheating of Device

  IT WAS REPORTED THAT WHEN THE SVC REPL,MDU, HAND CNTRL, PWRMX WAS PLUGGED IN UPON THE CONTROLLER, IT SHOW A FAULTY ERROR MESSAGE "BLADE STALL", ALSO THE HANDPIECE BECAME HOT AND AN ALARM WAS DISPLAYED. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656966 ↗
• MalfunctionNov 7, 2025Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS NOTICED THAT THE MOTOR DRIVE UNIT WAS OVERHEATING. THE PROCEDURE WAS PERFORMED WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501288 ↗
• MalfunctionOct 23, 2025Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT, THE MDU WAS VERY LOUD AND THE HANDPIECE WAS GETTING HOT. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367439 ↗
• MalfunctionOct 22, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, THE MDU SHAVER WAS GETTING HOT DURING USE. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364270 ↗
• MalfunctionOct 22, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MDU WAS OVERHEATING. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360649 ↗
• MalfunctionOct 20, 2025Overheating of Device; Unexpected Shutdown; Overheating of Device; Unexpected Shutdown

  IT WAS REPORTED THAT, THE MDU OVERHEATED TO HIGH TEMPERATURE AND STOPPED WORKING. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334164 ↗
• MalfunctionAug 8, 2025Failure to Shut Off; Physical Resistance/Sticking; Failure to Shut Off; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BUTTONS ON THE MDU WERE BROKEN AND DID NOT POP BACK UP ONCE PRESSED DOWN, IT MADE THE HANDPIECE TO RUN CONTINUOUSLY. THE BUTTON HAD TO BE PULLED UP TO SHUT THE DEVICE OFF. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A 5-MIN DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749990 ↗