NA 72200036Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010555700), received between Dec 21, 2017 and Jun 2, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Metal Shedding Debris” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC RIGHT SHOULDER STABILIZATION, AFTER 30 SECONDS OF DEBRIDING SOFT TISSUE, PARTICULARLY THE LABRUM, METAL SHAVINGS FROM THE CURVED INCISOR BLADE WERE OBSERVED IN THE GLENOHUMERAL JOINT SPACE. A STRAIGHT 4.5 SHAVER WAS OPENED TO REMOVE ALL THE SHAVINGS FROM THE PATIENT. THE SURGERY WAS COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22121510 ↗
• MalfunctionMar 13, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE TIP OF TWO (2) DYONICS 4.5 MM INCISOR PLUS PLATINUM WAS BENT AND THE INNER PART BROKE INSIDE THE PATIENT. THE PIECES WERE RECOVERED WITH TWEEZERS AND SUCTION. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW 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 21600552 ↗
• MalfunctionMar 13, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPIC PROCEDURE, THE TIP OF THE DYONICS 4.5 MM INCISOR PLUS PLATINUM BLADE WAS BENT AND BROKE. THE PIECES WERE RECOVERED WITH TWEEZERS AND SUCTION. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW 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 21600371 ↗
• MalfunctionDec 12, 2024Break; Activation Failure; Break; Activation Failure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CURVED INCISOR PLUS ELITE BLADE WAS MAKING THE OSCILLATING SOUND AS EXPECTED BUT WAS NOT TURNING THE BLADE TO RESECT THE TISSUE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20915928 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED THAT, DURING A RIGHT KNEE ARTHROSCOPY PROCEDURE, THE INCISOR ELITE PLUS STOPPED WORKING WHILE INSIDE THE JOINT, A LITTLE METAL PIECE WAS DISCOVERED, AND THEN REMOVED BY THE SURGEON USING FORCEPS. NO PIECE WAS LEFT INSIDE THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20203236 ↗
• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, A SMALL PART OF THE INCISOR BLADE DETACHED FROM THE SHAVER AND ENDED UP FLOATING INSIDE THE PATIENT'S KNEE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169551 ↗
• MalfunctionDec 19, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, METAL SHAVINGS WERE COMING OFF FROM THE 4.5MM INCISOR PLUS ELITE BLADE (OUTSIDE THE PATIENT). 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 16010647 ↗
• MalfunctionAug 6, 2019Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING A KNEE SCOPE, SOMETHING WAS RELEASED INSIDE THE PATIENT'S ANATOMY FROM THE DEVICE, AS PER REPORTER IT COULD BE OIL OR BLACK PIECES. NO PATIENT INJURIES OR DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THE BLACK "SCUFF" MARKS WERE REMOVED WITH ADDITIONAL SHAVING OF THE BACK-UP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8867755 ↗
• MalfunctionDec 21, 2017Metal Shedding Debris

  IT WAS REPORTED THAT DR. (B)(6) HAS BEEN EXPERIENCING METAL SHAVINGS, FROM THE SHAVER, IN THE JOINT DURING HIS CASES. HE HAS SEEN METAL SHAVINGS. GENERALLY IT HAPPENS IN HIS ACL AND SHOULDER CASES.

  Patient problems: Foreign Body In Patient

  MAUDE report 7139690 ↗
• MalfunctionDec 21, 2017Metal Shedding Debris

  IT WAS REPORTED THAT DR. (B)(6) HAS BEEN EXPERIENCING METAL SHAVINGS, FROM THE SHAVER, IN THE JOINT DURING HIS CASES. HE HAS SEEN METAL SHAVINGS. GENERALLY IT HAPPENS IN HIS ACL AND SHOULDER CASES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7139689 ↗
• MalfunctionDec 21, 2017Metal Shedding Debris

  IT WAS REPORTED THAT DR. (B)(6) HAS BEEN EXPERIENCING METAL SHAVINGS, FROM THE SHAVER, IN THE JOINT DURING HIS CASES. HE HAS SEEN METAL SHAVINGS. GENERALLY IT HAPPENS IN HIS ACL AND SHOULDER CASES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7139688 ↗
• MalfunctionDec 21, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT DR. (B)(6) HAS BEEN EXPERIENCING METAL SHAVINGS, FROM THE SHAVER, IN THE JOINT DURING HIS CASES. HE HAS SEEN METAL SHAVINGS. GENERALLY IT HAPPENS IN HIS ACL AND SHOULDER CASES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7139686 ↗
• MalfunctionDec 21, 2017Metal Shedding Debris

  IT WAS REPORTED THAT DR. (B)(6) HAS BEEN EXPERIENCING METAL SHAVINGS, FROM THE SHAVER, IN THE JOINT DURING HIS CASES. HE HAS SEEN METAL SHAVINGS. GENERALLY IT HAPPENS IN HIS ACL AND SHOULDER CASES.

  Patient problems: No Information

  MAUDE report 7139291 ↗
• MalfunctionDec 21, 2017Metal Shedding Debris

  IT WAS REPORTED THAT DR. (B)(6) HAS BEEN EXPERIENCING METAL SHAVINGS, FROM THE SHAVER, IN THE JOINT DURING HIS CASES. HE HAS SEEN METAL SHAVINGS. GENERALLY IT HAPPENS IN HIS ACL AND SHOULDER CASES.

  Patient problems: Test Result

  MAUDE report 7138886 ↗
• MalfunctionDec 21, 2017Metal Shedding Debris

  IT WAS REPORTED THAT DR. (B)(6) HAS BEEN EXPERIENCING METAL SHAVINGS, FROM THE SHAVER, IN THE JOINT DURING HIS CASES. HE HAS SEEN METAL SHAVINGS. GENERALLY IT HAPPENS IN HIS ACL AND SHOULDER CASES.

  Patient problems: Failure of Implant; Test Result

  MAUDE report 7138433 ↗