NA 7205332Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010251602), received between Aug 16, 2019 and Nov 28, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE BOXED INCISOR BLADE BROKE WHILE CLEANING THE TISSUE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY, THE DEVICE WAS NOT USED AGAIN. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20805703 ↗
• InjuryApr 19, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE USING A DYONICS CURVED INCISOR BLADE, METAL DEBRIS APPEARED IN THE JOINT SPACE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140704 ↗
• InjuryApr 19, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE USING A DYONICS CURVED INCISOR BLADE, METAL DEBRIS APPEARED IN THE JOINT SPACE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140686 ↗
• InjuryMay 14, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE BLADE WAS PROPERLY CONNECTED BUT DURING THE WHOLE PROCEDURE IT DID NOT WORK, IT DID NOT CUT THE TISSUE. THE SHAVER HANDPIECE AND THE SUCTION OF THE EQUIPMENT WERE CHECKED AND THEY WERE WORKING CORRECTLY BUT NOT THE BLADE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE OF A DIFFERENT REFERENCE. NO SIGNIFICANT DELAY AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826424 ↗
• MalfunctionNov 20, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ELBOW ARTHROSCOPY, THE CURVED INCISOR BLADE SNAPPED WHILE RESECTING. THE TIP OF THE INNER BLADE WAS STUCK INSIDE OF THE OUTER BLADE; OUTER BLADE APPEARS TO BE INTACT FROM VISUAL INSPECTION. ANOTHER BLADE WAS USED TO FINISH THE PROCEDURE AFTER A 10 MIN DELAY. THE PATIENT WAS NOT HARMED. 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 9351504 ↗
• MalfunctionAug 16, 2019Break; Mechanical Problem; Noise, Audible

  DURING A KNEE ARTHROSCOPY WHILE USING A SHAVER BLADE IT WAS NOTED THE INNER CANNULA SHAVING TEETH WAS NOT CIRCULATING/SPINNING LIKE USUAL AND MAKING A SQUEAKY NOSE. DOCTOR HANDED SHAVER TO SCRUB TECH. AT BACK TABLE, SCRUB TECH NOTED THE INNER CANNULA CAME RIGHT OUT AND INNER CANNULA'S TIP BROKE OFF AND REMAINED STUCK INSIDE THE OUTER SHAVER CANNULA. BOTH CANNULAS REMOVED FROM FIELD AND NEW SHAVER, SAME SIZE, OPENED WITHOUT PROBLEMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8900870 ↗