NA 72200617Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 03596010551559), received between Jul 23, 2018 and May 3, 2026 — classified as 2 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (45 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 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2026Overheating of Device

  IT WAS REPORTED THAT, THE MDU HEATED UP WHEN IN 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 25063037 ↗
• MalfunctionApr 5, 2026Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT, THE MDU WAS JAMMED, WOULD NOT SPIN AND GOT 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 24786778 ↗
• MalfunctionApr 4, 2026Overheating of Device

  IT WAS REPORTED THAT AN MDU OVERHEATED. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED. NO FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24785596 ↗
• MalfunctionDec 3, 2025Mechanical Problem; Overheating of Device; Mechanical Problem; Overheating of Device

  IT WAS REPORTED THAT, THE MDU HAD A SEIZED MOTOR AND 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 23706235 ↗
• MalfunctionJan 9, 2025Mechanical Problem; Overheating of Device; Mechanical Problem; Overheating of Device

  IT WAS REPORTED THAT, DURING SET UP FOR AN ACL PROCEDURE, THE MOTOR DRIVE UNIT HAD A BLADE STALL ERROR, AND IT GOT HEAT UP. THERE WAS A BACK-UP DEVICE AVAILABLE, AND A DELAY OF LESS THAN 30 MINUTES WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120423 ↗
• MalfunctionOct 1, 2024Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A A SHOULDER SURGERY, THE MDU ENGINE OF THE HANDLE SOMETIMES WORKED AND SOMETIMES NOT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344312 ↗
• MalfunctionSep 16, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE MDU HANDLE WAS VERY HOT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. THERE WAS NO DAMAGED CAUSED TO THE PATIENT OR USER BECAUSE OF THE MALFUNCTION AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225480 ↗
• MalfunctionMay 23, 2024Mechanical Problem; Overheating of Device; Mechanical Problem; Overheating of Device

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE MDU WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19385793 ↗
• MalfunctionMar 22, 2024Mechanical Problem; Overheating of Device; Output below Specifications; Insufficient Device Problem Information; Mechanical Problem; Overheating of Device; Output below Specifications; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING INSPECTION, THE MDU WAS BROKEN OR PRESENTED LOW RPM. 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 18958739 ↗
• MalfunctionJan 4, 2024Mechanical Problem; Overheating of Device; Mechanical Problem; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP, THE MOTOR OF THE MDU WAS NOT WORKING. THERE WAS A BACK-UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT. AS PER INVESTIGATION RESULTS, A BLADE STALL ERROR AND OVERHEATING OF THE HOUSING WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444419 ↗
• MalfunctionNov 8, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED REPORTED THAT THE MOTOR DRIVE UNIT WAS PLUGGED IN, STARTED AND THEN IT STOPPED WORKING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. UPON INVESTIGATION, IT WAS FOUND A BLADE STALL ERROR AND OVERHEATING OF THE HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097850 ↗
• MalfunctionNov 3, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, DURING TESTING THE MOTOR DRIVE UNIT WAS NOT PROVIDING THE PROPER RPMS. AS THIS WAS NOTICED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT. AS PER INVESTIGATION RESULTS, IT WAS FOUND A BLADE STALL ERROR AND OVERHEATING OF THE HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070154 ↗
• MalfunctionOct 4, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT WAS NOT WORKING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION REVEALED A BLADE STALL ERROR AND OVERHEATING OF THE HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869126 ↗
• MalfunctionOct 3, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT PRESENTED A BLADE STALL ERROR AND OVERHEATING OF THE HOUSING. THE DEFICIENCY WAS OBSERVED WHILE PERFORMING THE INVESTIGATION FOR THE DEVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860300 ↗
• MalfunctionAug 17, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MDU HAD A BLADE STALL ERROR AND OVERHEATING OF THE HOUSING. THE DEFICIENCY WAS OBSERVED WHILE PERFORMING THE INVESTIGATION FOR THE DEVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569455 ↗
• MalfunctionJul 18, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT WAS NOT WORKING PROPERLY. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED. AS 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 17344021 ↗
• MalfunctionJul 13, 2023Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT THE HOUSING OF THE MOTOR DRIVE UNIT WAS OVERHEATING AND IT PRESENTED A BLADE STALL ERROR. THE DEFICIENCY WAS OBSERVED WHILE PERFORMING THE INVESTIGATION FOR THE DEVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321305 ↗
• MalfunctionJul 13, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MDU WAS NOT WORKING. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. AS PER RESULTS OF INVESTIGATION AN OVERHEATING OF THE HOUSING WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17318670 ↗
• MalfunctionJun 26, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MDU WAS NOT WORKING. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. AS PER INVESTIGATION RESULTS, A BLADE STALL ERROR AND OVERHEATING OF THE HOUSING WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17204349 ↗
• MalfunctionJun 20, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC SURGERY, THE MOTOR DRIVE UNIT WAS OVERHEATING. A REPLACEMENT WAS IMMEDIATELY USED TO COMPLETE THE SURGERY WITHOUT CAUSING HARM TO THE PATIENT. NON-SIGNIFICANT DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17166657 ↗
• MalfunctionFeb 8, 2023Mechanical Problem; Overheating of Device; Self-Activation or Keying; Mechanical Problem; Overheating of Device; Self-Activation or Keying

  IT WAS REPORTED THAT, DURING SET UP, THE MDU KEPT SPINNING/WORKING AFTER PEDALS WERE NO LONGER BEING PUSHED. 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 16324799 ↗
• MalfunctionNov 29, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP, THE MDU WAS OVERHEATING. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880123 ↗
• MalfunctionOct 31, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC DEBRIDEMENT OF SHOULDER, THE MDU OVERHEATED WHILE BEING USED WITH A DII CONTROLLER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698555 ↗
• MalfunctionJun 15, 2022Overheating of Device; Activation Failure; Overheating of Device; Activation Failure

  IT WAS REPORTED THAT DURING SET UP FOR AN UNSPECIFIED PROCEDURE, THE MOTOR DRIVE UNIT COULD NOT WORK. THERE WAS NO RESPONSE WHEN THE BUTTON WAS PRESSED AND IT GOT VERY HOT. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS A NON-SIGNIFICANT DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14692476 ↗
• MalfunctionDec 7, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE MDU BECOME VERY HOT AND STOPPED WORKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12956167 ↗