NA 72200872Recalls & reported problems

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 03596010618894), received between Nov 5, 2018 and Jan 19, 2026 — classified as 174 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (82 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 174 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2026Overheating of Device

  IT WAS REPORTED THAT, DURING SURGERY, AN MDU WAS RUNNING HOT. THE PROCEDURE WAS RESUMED, 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 24108795 ↗
• MalfunctionDec 1, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE POWER MAX ELITE MDU WAS OVERHEATING. A BACK UP DEVICE WAS AVAILABLE. 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 23687024 ↗
• MalfunctionSep 25, 2025Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT BEFORE A PROCEDURE, IT WAS NOTICED THAT THE MDU WAS OVERHEATING. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23149692 ↗
• MalfunctionMay 6, 2025Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT THE MDU WAS GETTING SO HOT THAT THE STAFF COULD NOT HOLD IT. 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 A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972291 ↗
• MalfunctionJul 16, 2024Mechanical Problem; Overheating of Device; Mechanical Problem; Overheating of Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE MDU WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY OF 5 MINUTES, USING A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19756844 ↗
• MalfunctionJun 18, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, DURING SET UP, THE MDU WAS GETTING VERY HOT. THERE WAS A BACK-UP DEVICE AVAILABLE, AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19561996 ↗
• MalfunctionJun 17, 2024Mechanical Problem; Overheating of Device; Insufficient Device Problem Information; Mechanical Problem; Overheating of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE MDU WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19551569 ↗
• MalfunctionJun 3, 2024Mechanical Problem; Overheating of Device; Insufficient Device Problem Information; Mechanical Problem; Overheating of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE MDU WAS NOT WORKING. IT IS UNKNOWN WHEN THE EVENT TOOK PLACE, IF THERE WAS PATIENT INVOLVEMENT, IF THERE WAS A BACK UP DEVICE AVAILABLE. NO DELAY WAS REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19453567 ↗
• MalfunctionMay 27, 2024Mechanical Problem; Overheating of Device; Activation Failure; Mechanical Problem; Overheating of Device; Activation Failure

  IT WAS REPORTED THAT THE MDU DID NOT TURN ON. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19401184 ↗
• MalfunctionMay 20, 2024Mechanical Problem; Overheating of Device; Mechanical Problem; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP THE MDU DID NOT WORK WHEN PLUGGED IN. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354739 ↗
• MalfunctionMay 17, 2024Mechanical Problem; Overheating of Device; Insufficient Device Problem Information; Mechanical Problem; Overheating of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING SET UP FOR A PROCEDURE, THE MOTOR DRIVE UNIT DID NOT WORK. THERE WAS A BACK-UP DEVICE AVAILABLE AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19343254 ↗
• MalfunctionMay 7, 2024Mechanical Problem; Overheating of Device; Insufficient Device Problem Information; Mechanical Problem; Overheating of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE MDU STOPPED WORKING NORMALLY. IT IS UNKNOWN WHEN THE EVENT TOOK PLACE, IF THERE WAS PATIENT INVOLVEMENT. THERE WAS A BACK UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19259446 ↗
• MalfunctionMay 6, 2024Mechanical Problem; Overheating of Device; Insufficient Device Problem Information; Mechanical Problem; Overheating of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE MDU STOPPED WORKING NORMALLY. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. THERE WAS A SMITH AND NEPHEW BACK-UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19254198 ↗
• MalfunctionMay 3, 2024Mechanical Problem; Overheating of Device; Insufficient Device Problem Information; Mechanical Problem; Overheating of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE MDU STOPPED WORKING NORMALLY. IT IS UNKNOWN WHEN THE EVENT TOOK PLACE, IF THERE WAS PATIENT INVOLVEMENT. THERE WAS A BACK UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19242649 ↗
• MalfunctionMay 2, 2024Mechanical Problem; Overheating of Device; Insufficient Device Problem Information; Mechanical Problem; Overheating of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE MDU STOPPED WORKING NORMALLY. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE AND NO DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234476 ↗
• MalfunctionApr 29, 2024Mechanical Problem; Overheating of Device; Insufficient Device Problem Information; Mechanical Problem; Overheating of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE MDU STOPPED WORKING NORMALLY. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. THERE WAS A BACK-UP DEVICE AVAILABLE, AND NO DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209761 ↗
• MalfunctionApr 25, 2024Mechanical Problem; Overheating of Device; Insufficient Device Problem Information; Mechanical Problem; Overheating of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE MDU STOPPED WORKING NORMALLY. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. THERE WAS A SMITH AND NEPHEW BACK-UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19188008 ↗
• MalfunctionApr 25, 2024Mechanical Problem; Overheating of Device; Insufficient Device Problem Information; Mechanical Problem; Overheating of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE MDU STOPPED WORKING NORMALLY. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE AND NO DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19184916 ↗
• MalfunctionApr 11, 2024Mechanical Problem; Overheating of Device; Insufficient Device Problem Information; Mechanical Problem; Overheating of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT STOPPED WORKING. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087340 ↗
• MalfunctionJan 25, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP, THE MDU WAS NOT POWERING UP. THERE WAS A SMITH AND NEPHEW BACK-UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT. PER THE RESULTS OF THE INVESTIGATION, THE FUNCTIONAL EVALUATION REVEALED AN OVERHEATING OF THE HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581286 ↗
• MalfunctionJan 5, 2024Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT DURING SET UP, THE MOTOR DRIVE UNIT´S MOTOR WAS BAD, IT WAS VERY HOT AND NOT RUNNING. THERE WAS NO DELAY REPORTED AND A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18449887 ↗
• MalfunctionNov 17, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP OF A PROCEDURE, THE MOTOR DRIVE UNIT WAS NOT RESPONDING TO FOOT OR HAND CONTROL IN PORT A OR B. BACK UP DEVICE WAS AVAILABLE. NO SURGICAL DELAY NOR FURTHER COMPLICATIONS WERE REPORTED. PER THE RESULTS OF THE INVESTIGATION, THE FUNCTIONAL EVALUATION REVEALED AN OVERHEATING OF THE HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165211 ↗
• MalfunctionNov 17, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT MDU HAD A MOTOR FAULT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. PER THE RESULTS OF THE INVESTIGATION, THE FUNCTIONAL EVALUATION REVEALED AN OVERHEATING OF THE HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165137 ↗
• MalfunctionNov 16, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP OF A PROCEDURE, THE MOTOR DRIVE UNIT WAS NOT RESPONDING TO THE FOOT CONTROL AND CONTROL MACHINE. THERE WAS A BACK-UP DEVICE AVAILABLE AND NO DELAY WAS REPORTED. NO PATIENT INVOLVEMENT. RESULTS OF INVESTIGATION REVEALED A BLADE STALL ERROR AND OVERHEATING OF THE HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155687 ↗
• MalfunctionOct 3, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DYONICS POWERMAX HANDPIECE WAS NOT WORKING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. PER THE RESULTS OF INVESTIGATION, THE FUNCTIONAL EVALUATION REVEALED AN OVERHEATING OF THE HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860602 ↗