NA 72201518Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 03596010621672), received between Dec 29, 2017 and Sep 3, 2025 — classified as 9 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE ABRADER'S INNER BLADE BROKE. ALL PIECES WERE REMOVED FROM THE PATIENT. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954754 ↗
• MalfunctionJul 17, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, METAL FRAGMENTS APPEARED DURING THE USE OF THE GRINDING ABRADER BLADE HEAD. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19764787 ↗
• MalfunctionMar 10, 2024Break; Dent in Material; Material Deformation; Break; Dent in Material; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A WHITE MATERIAL OF THE TIP OF THE ABRADER TORN, IT WAS PART OF THE INNER BLADE. AND IT ALSO BROKE ON THE UPPER PART OF THE BLADE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18872226 ↗
• MalfunctionMay 12, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ABRADER'S INNER BLADE BROKE INTO PIECES. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16923887 ↗
• InjuryAug 21, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE ABRADER BLADE CREATED METAL FLAKE. UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE TO COMPLETE THE SURGERY. NO DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15263547 ↗
• InjuryMar 28, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE INNER BLADE OF THE ABRADER BURR, BROKE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 10 MINUTES DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13925558 ↗
• InjuryMar 28, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE INNER BLADE OF THE ABRADER BURR, BROKE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 10 MINUTES DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13925556 ↗
• InjuryDec 15, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ABRADER 2.9 BLADE WAS BROKEN. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NON-SIGNIFICANT DELAY AND NO ADDITIONAL COMPLICATIONS WERE REPORTED. THE PATIENT IS RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13013324 ↗
• MalfunctionMay 4, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING ANKLE ARTHROSCOPY PROCEDURE, INSIDE THE PATIENT, THE ABRADER 2.9 MAG-MINI DISP. BLADE STARTED TO SHRED SMALL FRAGMENTS OF METAL FROM THE BURR INSIDE OF THE JOINT. THE FRAGMENTS WERE REMOVED BY USING A SOFT TISSUE SHAVER ON SUCTION. THEY THEN USED A REPLACEMENT PRODUCT FROM THE SAME BATCH IN THE SAME WAY BUT THE SAME ISSUE OCCURRED WITH THE REPLACEMENT AS WELL. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE, NO SURGICAL DELAY AND PATIENT INJURIES WERE NOT 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 11773872 ↗
• MalfunctionMay 4, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING ANKLE ARTHROSCOPY PROCEDURE, INSIDE THE PATIENT, THE ABRADER 2.9 MAG-MINI DISP. BLADE STARTED TO SHRED SMALL FRAGMENTS OF METAL FROM THE BURR INSIDE OF THE JOINT. THE FRAGMENTS WERE REMOVED BY USING A SOFT TISSUE SHAVER ON SUCTION. THEY THEN USED A REPLACEMENT PRODUCT FROM THE SAME BATCH IN THE SAME WAY BUT THE SAME ISSUE OCCURRED WITH THE REPLACEMENT AS WELL. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE, NO SURGICAL DELAY AND PATIENT INJURIES WERE NOT 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 11773871 ↗
• InjuryMar 20, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ANKLE SYNOVECTOMY SURGERY, INTERNAL TO THE PATIENT, THE ABRADER BLADE DETACHED SMALL PARTICLES IN THE PATIENT´S JOINT. ALL PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11536688 ↗
• InjurySep 20, 2020Material Fragmentation; Material Separation; Material Fragmentation; Material Separation

  IT WAS REPORTED THAT, DURING A WRIST ARTHROSCOPIC SURGERY USING A "2.9MM ABRADER BLADE", METAL PIECES WERE FOUND WHILE REMOVING THE SCLEROTIC BONE. THE METALLIC PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE PIECES WERE REMOVED USING TWEEZERS AND SUCTION. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10558141 ↗
• InjurySep 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A WRIST ARTHROSCOPIC SURGERY USING A "2.9MM ABRADER BLADE", METAL PIECES WERE FOUND WHILE REMOVING THE SCLEROTIC BONE. THE METALLIC PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE PIECES WERE REMOVED USING TWEEZERS AND SUCTION. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10558139 ↗
• InjurySep 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A WRIST ARTHROSCOPIC SURGERY USING A POWERMINI ABRADER BURR IT WAS FOUND METAL PIECES WHILE REMOVING THE SCLEROTIC BONE. THE PIECES WERE REMOVED USING TWEEZERS AND SUCTION. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A SIGNIFICANT DELAY. 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 Information

  MAUDE report 10511212 ↗
• InjurySep 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A WRIST ARTHROSCOPIC SURGERY USING A POWERMINI ABRADER BURR IT WAS FOUND METAL PIECES WHILE REMOVING THE SCLEROTIC BONE. THE PIECES WERE REMOVED USING TWEEZERS AND SUCTION. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A SIGNIFICANT DELAY. 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 Information

  MAUDE report 10511073 ↗
• MalfunctionApr 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE FOOT JOINT PROCEDURE, WHEN THE DEVICE WAS USED, THE CENTER OF THE BLADE WAS BROKEN. IT IS UNKNOWN IF THERE WERE DELAYS OR A BACK UP AVAILABLE. NO PATIENT HARM WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9980172 ↗
• MalfunctionDec 9, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHEN THE ABRADER WAS INSERTED AND AS IT APPROACHED THE JOINT, THE OUTER TUBE BENT AND THE INNER BLADE BROKE. NO BACKUP DEVICE WAS AVAILABLE. NO DELAY OR PATIENT INJURY WAS 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 9438952 ↗
• MalfunctionMay 20, 2019Material Fragmentation; Noise, Audible; Device Fell

  IT WAS REPORTED THAT DURING A HAND ARTHROSCOPY THE MINI SHAVER BURR HAD A LOT OF METAL DEBRIS FALLING OFF AND IT MADE A SQUEAKING SOUND WHEN OSCILLATING SO THEY HAD TO UNPACK ANOTHER SHAVER BURR WHICH THEN WORKED FINE. NO DELAY OR PATIENT INJURIES WERE REPORTED. THE METAL DEBRIS FELL OFF IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8624238 ↗
• MalfunctionDec 29, 2017Flaked

  IT WAS REPORTED THAT THE DEVICE WAS SHEDDING OR FLAKING. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7154037 ↗