NA 72200616FRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 03596010601209), received between Feb 15, 2018 and Mar 18, 2026 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (25 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Electrical /Electronic Property Problem; Overheating of Device; Mechanical Jam; Noise, Audible

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE, THE MDU WAS GENERATING NOISE AND BECAME HOT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626717 ↗
• MalfunctionMar 15, 2026Overheating of Device; Mechanical Jam; Noise, Audible

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE, THE MDU WAS GENERATING NOISE AND BECAME HOT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24601686 ↗
• MalfunctionJan 27, 2026Mechanical Problem; Overheating of Device

  IT WAS REPORTED THAT BEFORE A HIP ARTHROSCOPY PROCEDURE, IT WAS NOTICED THAT THE MDU WAS OVERHEATING. THE PROCEDURE WAS PERFORMED WITHOUT ANY DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO DAMAGE TO USER OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193192 ↗
• MalfunctionFeb 29, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP THE MOTOR DRIVE UNIT WAS RUNNING HOT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809225 ↗
• MalfunctionJun 21, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE MOTOR DRIVE UNIT WAS NO LONGER WORKING, THE BLADE DID NOT TURN. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. AS PER RESULTS OF INVESTIGATION, OVERHEATING OF THE HOUSING WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172312 ↗
• MalfunctionAug 2, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP OF A KNEE PROCEDURE, THE MDU HAD HIGH TEMPERATURE WHEN CONNECTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15153249 ↗
• MalfunctionJul 28, 2022Corroded; Overheating of Device; Noise, Audible; Corroded; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT, THE DYONICS POWERMAX SHAVER HANDPIECE DEVICE WAS RUNNING HOT. THE PROBLEM WAS NOTICED DURING USE, NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15123224 ↗
• MalfunctionMar 24, 2022Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE MDU HAND CONTROL PRESENTED ENGINE WEAR, HEATING, SOUND AND VIBRATION. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13872861 ↗
• MalfunctionMar 9, 2022Electrical /Electronic Property Problem; Overheating of Device; Electrical /Electronic Property Problem; Overheating of Device

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT WAS HOT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13703461 ↗
• MalfunctionNov 15, 2021Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12815031 ↗
• MalfunctionApr 30, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT WAS NOT WORKING. NO CASE WAS INVOLVED. NO FURTHER DETAILS AVAILABLE. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A JAMMED MOTOR 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11752574 ↗
• MalfunctionApr 26, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING SET UP FOR A KNEE SURGERY, THE "MDU POWERMAX ELITE SHAVER" THREW AN ERROR IN THE CONSOLE. IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE OR IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A JAMMED MOTOR 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11723562 ↗
• MalfunctionApr 6, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE RFB MDU HAND CNTRL PWRMX EL OVERHEATED AND STOPPED WORKING. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. ALSO UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IS THERE WAS ANY DELAY. 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 11619342 ↗
• MalfunctionMar 7, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE RFB, MDU, HAND CNTRL, PWRMX EL GETS HOT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11429794 ↗
• MalfunctionFeb 15, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT GOT HOT WHILE TESTING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11329958 ↗
• MalfunctionFeb 11, 2021Mechanical Jam; No Apparent Adverse Event; Mechanical Jam; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE "MDU POWERMAX ELITE SHAVER" DID NOT WORK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT DURING A FUNCTIONAL EVALUATION, THE DEVICE PRESENTED JAMMED MOTOR/BLADE STALL ERROR, 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11313222 ↗
• MalfunctionFeb 6, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE, THE RFB MDU HAND CNTRL PWRMX EL WAS GETTING HOT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY, HOWEVER IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 11290304 ↗
• MalfunctionFeb 3, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT WOULD NOT TURN ON. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. RESULTS OF INVESTIGATION REVEALED A HANDPIECE STALL WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273139 ↗
• MalfunctionJan 7, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE MOTOR DRIVE UNIT WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT WAS JAMMED WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11133963 ↗
• MalfunctionJan 4, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE CORD OF MDU GETS REALLY HOT AND THROW ERROR MESSAGE. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. 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 11113715 ↗
• MalfunctionDec 3, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE PROCEDURE, THE MDU BUTTONS WERE STALL AND RUNNING HOT. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. 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 10937974 ↗
• MalfunctionNov 12, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT WAS NOT WORKING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A JAMMED MOTOR/BLADE STALL 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 Patient Involvement

  MAUDE report 10831397 ↗
• MalfunctionAug 19, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE HANDPIECE GOT HOT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO DELAY OR COMPLICATIONS WERE REPORTED. 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 10426315 ↗
• MalfunctionAug 10, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING KNEE SCOPE PROCEDURE, THE PRONGS OF THE MOTOR DRIVE UNIT WERE BROKEN. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A JAMMED MOTOR; THEREFORE, 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 10388846 ↗
• MalfunctionJun 24, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING PROCEDURE, THE MDU WAS LOCK. NO DELAY AND A BACK UP WAS USED TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED. 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 10193010 ↗