NA 72200722Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010578006), received between Jan 11, 2018 and May 21, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Flaked

  IT WAS REPORTED THAT DURING A ELBOW SCOPE PROCEDURE, THE 4.0MM ELITE ABRADER BURR HAD EXCESS AMOUNT OF SHEDDING FROM BURR BLADE OCCURRED DURING BONY WORK OF SCOPE. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING THE SAME S+N PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242701 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, AN ELITE ABRADER BURR BROKE INSIDE THE BURR SHEATH. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. 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 25161230 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TIP OF AN ABRADER BLADE CAME OFF FROM THE SHAFT. THE TIP DID NOT FALL INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376832 ↗
• MalfunctionJun 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE BLADE ELITE ABRADER WAS DETACHED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525007 ↗
• MalfunctionOct 25, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ELITE BLADE WAS BROKEN. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 5 MINUTE DELAY USING A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007988 ↗
• InjuryMar 21, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ELBOW ARTHROSCOPY, A BURR ON A SHORT SHEATH WAS USED. WHEN STARTING TO USE THE BURR, IT WAS NOTED THAT SMALL FRAGMENTS OF METAL WERE PRESENT IN THE ELBOW CAVITY, THEY WERE NOT VISIBLE TO THE NAKED EYE, IT WAS MAGNIFIED BY AN ARTHROSCOPY CAMERA AND TV SCREEN. THE SURGEON STOPPED USING THE BURR AND SWAPPED IT TO A SHAVER. THEY TRIED TO REMOVE AS MUCH OF THE METAL FRAGMENT AS POSSIBLE, THEY USED A MAGNETIC SCREWDRIVER TIP TO TRY AND PICK UP SOME OF THE REMAINING FRAGMENTS. THEY WERE UNABLE TO DETERMINE IF FRAGMENTS CAME FROM THE BURR OR THE SHEATH. A NON-SIGNIFICANT DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16586727 ↗
• InjuryMar 3, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE DYONICS ELITE INNER BLADE BROKE INTO PIECES. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. 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 13657723 ↗
• InjuryMar 19, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE SURGERY THE BLADE SHAFT BROKE INSIDE THE PATIENT. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11522254 ↗
• MalfunctionJun 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A FOOT JOINT SURGERY, THE TIP OF THE "4.0MM ELITE ABRADER BLADE" CAME OFF IMMEDIATELY AFTER OPENING THE PACKAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES 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 Known Impact Or Consequence To Patient

  MAUDE report 10135935 ↗
• MalfunctionJan 11, 2018Metal Shedding Debris

  IT WAS REPORTED THAT THE DEVICE SHED METAL SHAVINGS, ALL WERE REMOVED FROM THE PATIENT. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Test Result

  MAUDE report 7181796 ↗