NA 7206010Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 03596010440235), received between Oct 9, 2020 and Jul 2, 2026 — classified as 7 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Flaked” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A SURGERY, WHILE USING ONE (1) FULL RADIUS BLADE, METAL SHAVINGS WERE OBSERVED DURING THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THE SHAVINGS WERE REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED AND WHETHER A SURGICAL DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25699101 ↗
• MalfunctionApr 30, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING SHOULDER ARTHROSCOPY, METAL SHAVINGS OF THREE (3) FULL RADIUS BLADE WERE OBSERVED EVERYWHERE IN THE SHOULDER. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044937 ↗
• MalfunctionMar 20, 2026Material Fragmentation

  IT WAS REPORTED THAT, AN UNKNOWN QUANTITY OF FULL RADIUS BLADES WERE LEAVING METAL PARTICLES INTO THE SURGICAL SITE DURING USE. IT IS UNKNOWN THE EXACT NUMBER OF PATIENTS WHO EXPERIENCED THIS ISSUE, HOW THESE SURGERIES WERE COMPLETED, OR THE OUTCOMES FOR THE PATIENTS INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651470 ↗
• MalfunctionMar 20, 2026Material Fragmentation

  IT WAS REPORTED THAT, AN UNKNOWN QUANTITY OF FULL RADIUS BLADES WERE LEAVING METAL PARTICLES INTO THE SURGICAL SITE DURING USE. IT IS UNKNOWN THE EXACT NUMBER OF PATIENTS WHO EXPERIENCED THIS ISSUE, HOW THESE SURGERIES WERE COMPLETED, OR THE OUTCOMES FOR THE PATIENTS INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651469 ↗
• MalfunctionMar 20, 2026Material Fragmentation

  IT WAS REPORTED THAT, AN UNKNOWN QUANTITY OF FULL RADIUS BLADES WERE LEAVING METAL PARTICLES INTO THE SURGICAL SITE DURING USE. IT IS UNKNOWN THE EXACT NUMBER OF PATIENTS WHO EXPERIENCED THIS ISSUE, HOW THESE SURGERIES WERE COMPLETED, OR THE OUTCOMES FOR THE PATIENTS INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651452 ↗
• MalfunctionOct 31, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING A NOTCHPLASTY PROCEDURE, METAL DEBRIDEMENT WAS SEEN IN THE JOINT OF THE PATIENT AFTER USING ONE (1) RADIUS BLADE 5.5MM TO SHAVE HARD BONE. IT IS UNKNOWN IF THERE WAS A SMITH AND NEPHEW BACKUP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442069 ↗
• MalfunctionAug 7, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING A SUBACROMIAL DECOMPRESSION, METAL SHAVINGS OF THE FULL RADIUS BADE WERE FOUND WITHIN THE JOINT. THE METAL DEBRIS WAS RETRIEVED THROUGH THE OSCILLATE MODE ON THE SHAVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739023 ↗
• MalfunctionJul 29, 2025Flaked; Flaked

  IT WAS REPORTED THAT, DURING A SUBACROMIAL DECOMPRESSION, METAL SHAVINGS WERE FOUND WITHIN THE JOINT AFTER THE USE OF THE FULL RADIUS BLADE 5.5MM. IT IS UNKNOWN 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 22646310 ↗
• MalfunctionJul 28, 2025Flaked; Flaked

  IT WAS REPORTED THAT ONE (1) FULL RADIUS BLADE 5.5MM OFF THE FIELD OF A CASE, WAS SHEDDING METAL DEBRIS. IT IS UNKNOWN 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 22628244 ↗
• MalfunctionJul 21, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING A SUBACROMIAL DECOMPRESSION, METAL SHAVING DEBRIS WERE SHED AND FOUND WITHIN THE JOINT AFTER USING ONE (1) FULL RADIUS BLADE 5.5MM, IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22562247 ↗
• MalfunctionJul 20, 2025Flaked; Flaked

  IT WAS REPORTED THAT, DURING A SUBACROMIAL DECOMPRESSION, METAL SHAVINGS WERE FOUND WITHIN THE JOINT AFTER THE USE OF THE FULL RADIUS BLADE 5.5MM. THE METAL DEBRIS WAS RETRIEVED FROM THE PATIENT THROUGH THE OSCILLATE MODE ON THE SHAVER. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD; A BLADE OF DIFFERENT SIZE WAS USED. IT IS UNKNOWN IF THERE WAS A DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552588 ↗
• InjuryJun 20, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, ONE (1) FULL RADIUS BLADE 5.5MM WAS HAVING METAL SHAVING ISSUES. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303319 ↗
• MalfunctionJun 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE WITH A SAD PROCEDURE, METAL DEBRIDEMENT WAS SEEN IN THE JOINT AFTER USING THE 5.5MM FULL RADIUS BLADE. THE METAL DEBRIS WAS SUSPECTED TO HAVE ORIGINATED FROM THE BLADE WHILE IT WAS SHAVING HARD BONE. THE METAL DEBRIS WERE REMOVED FROM INSIDE THE PATIENT USING THE 4.5 BONECUTTER ON OSCILLATE MODE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY OF 1-2 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166896 ↗
• MalfunctionJun 5, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A PROCEDURE THE BONECUTTER BLADE PRODUCED METAL SHAVINGS/DEBRIS. ALL THE SHRED MATERIAL WAS REMOVED FROM THE PATIENT WITH OSCILLATION MODE IN THE SHAVER. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A SURGICAL DELAY OF 1-5 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150082 ↗
• MalfunctionApr 8, 2024Flaked; Material Deformation; Flaked; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN USING TWO (2) FULL RADIUS BLADES, IT SEEMED TO BE SHREDDING OFF A LITTLE METAL AND ON REMOVAL FROM PATIENT THE INNER BLADE HAD WHAT LOOKED LIKE A BURN RING MARK AROUND THE BASE OF THE TUBE ABOUT 0.5CM FROM THE CONNECTOR TO THE HANDPIECE. 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 19060635 ↗
• InjurySep 28, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE PROCEDURE, THE DYONICS BONE CUTTER BLADE FAILED. THE CONSOLE ALARMED, THE DEVICE WAS REMOVED AND THE SCRUB NURSE WAS NOT HAPPY WITH THE END OF THE BONE CUTTER. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. AS PER PRELIMINARY INVESTIGATION RESULTS, BURRS AND DAMAGE WERE FOUND TO THE BLADE EDGE OF THE INNER BLADE. MOREOVER, THE OUTER BLADE HAS A METAL SHAVING AT THE LOWER FRONT LIP. THERE IS BIO DEBRIS IN AND ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15495768 ↗
• InjuryNov 7, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY OF THE SHOULDER, METAL FRAGMENTS WERE COMING OFF THE FULL RADIUS BLADE AND FLOATING IN THE IRRIGATION FLUID. THE MAJORITY OF THE FRAGMENTS WERE SAFELY REMOVED THROUGH IRRIGATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12763404 ↗
• InjuryMay 13, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING A LEFT SHOULDER SCOPE, THREE RADIUS BLADES WERE FLAKING OFF METAL SHAVINGS INSIDE THE PATIENT WHERE THE EXTERNAL SHEATH OF THE SHAVER AND THE INTERNAL SHEATH WERE RUBBING TOGETHER. THE METAL FLAKES WERE RETRIEVED BY SUCTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO DELAY WAS REPORTED, AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11823143 ↗
• InjuryJan 2, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE, THE SHAVER WAS NOT RESECTING AS NEEDED AND THE BLADE WAS RUBBING ON THE OUTER SHEATH, CAUSING THE SHAVER BLADE TO CHIPPED OFF METAL PIECES INTO THE PATIENT'S JOINT. ALL PIECES WERE REMOVED WITH SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT 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 11104595 ↗
• InjuryDec 23, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING SHOULDER SCOPE PROCEDURE, THE FULL RADIUS BLADE WAS NOT RESECTING AS NEEDED AND THE BLADE WAS RUBBING ON THE OUTERSHEATH LEAVING METAL SHAVINGS BEHIND IN THE JOINT. ALL PIECES WERE REMOVED FROM PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR OTHER COMPLICATIONS. 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 11065666 ↗
• InjuryOct 9, 2020Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE SURGERY, WHEN THE SURGEON STARTED TO USE THE BLADE, IT DROPPED METAL IN THE SHOULDER. ADDITIONALLY, IT WAS STATED THAT THE BLADE WAS BEING USED ON SOFT TISSUE, NO BONE WORK. ANOTHER BLADE WAS USED TO COMPLETE THE SURGERY AND TO REMOVE ALL METAL PIECES. NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS 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; No Information

  MAUDE report 10656153 ↗