NA 7205345Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 03596010251688), received between Feb 8, 2018 and Mar 8, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Break” (8 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.

• MalfunctionMar 8, 2026Break

  IT WAS REPORTED THAT, DURING AN LCP PROCEDURE, AN INCISOR SHAVER BLADE BROKE WHEN SURGEON BEGAN TO SHAVE THE PATIENT'S CARTILAGE, AND IT BECAME VERY HARD. NO PIECES OF THE DEVICE FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542185 ↗
• MalfunctionJan 9, 2026Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE INNER PART OF ONE (1) BOXED INCISOR BLADE BROKE, PREVENTING IT FROM OSCILLATING AND BECOMING COMPLETELY STUCK. THE BLADE WAS TAKEN OUT OF THE PATIENT INTACT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023693 ↗
• MalfunctionDec 23, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY AND BILATERAL OSTEOCHONDROPLASTY PROCEDURE, WHILE USING THE INCISOR PLUS BLADE ON A KNEE WITH SIGNIFICANT FIBROSIS, THE BLADE BECAME BENT AND BROKE WHEN IT WAS STRAIGHTENED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877627 ↗
• MalfunctionSep 8, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE SEAL OF (B)(4) UNITS OF THE BOXED INCISOR PLUS BL WAS TURNED AND COULDN¿T BE REPLACED, THEREFORE, THEY NO LONGER FIT INTO THE SHAVER. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992145 ↗
• MalfunctionAug 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY, THE TIP OR END OF THE INCISOR BLADE SNAPPED OFF. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. IT IS UNKNOWN HOW WAS THE SURGERY COMPLETED. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883947 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY, THE TIP END OF ONE (1) INCISOR PLUS BLADE SNAPPED OFF. THE BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY. THE PROCEDURE WAS RESUMED, USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861020 ↗
• MalfunctionFeb 11, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE INCISOR PLUS BLADE BROKE BECAUSE OF RIGID FIBROSIS IN THE PATIENT'S KNEE. THE PIECES WERE REMOVED FROM INSIDE THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354689 ↗
• MalfunctionJan 14, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING A SYNOVECTOMY OPERATION, WHILE THE INSTRUMENT WAS INSIDE THE PATIENT, WHEN ONE OF THE BOXED INCISOR PLUS WAS BEING USED, THE SURGEON SUDDENLY OBSERVED METALLIC POWDER ON THE SCREEN AND IMMEDIATELY SUCTION FOR CLEANING, THE METALLIC POWDER WAS REMOVED FROM THE PATIENT WITH SUCTION. THE PROCEDURE WAS SUCCESSFULLY 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 21148183 ↗
• MalfunctionNov 20, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THERE WERE METAL PIECES COMING OFF FROM THE INCISOR PLUS BLADE INTO THE PATIENT'S KNEE. 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 20734996 ↗
• MalfunctionOct 20, 2024Break; Delivered as Unsterile Product; Material Split, Cut or Torn; Break; Delivered as Unsterile Product; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE INCISOR PLUS PACKAGING WAS CRUSHED AND BROKEN. THE SURGEON MENTIONED THAT IT WAS NO LONGER STERILE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490356 ↗
• MalfunctionAug 6, 2024Material Fragmentation; Suction Problem; Material Fragmentation; Suction Problem

  IT WAS REPORTED THAT DURING AN ELBOW DEBRIDEMENT, THE BLADE PRODUCED SLIGHT IRON FILINGS AND SOON BECAME CLOGGED. AFTER UNSUCCESSFUL ATTEMPTS AT CLEANING AND DREDGING, A DOUBLE-TOOTH BLADES WERE REPLACED AND USED AS A BACK UP DEVICE TO COMPLETE THE OPERATION. THE SHRED FRAGMENTS WERE REMOVED FROM THE PATIENT USING SUCTION. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19922342 ↗
• MalfunctionApr 16, 2024Flaked; Material Integrity Problem; Mechanical Jam; Insufficient Device Problem Information; Flaked; Material Integrity Problem; Mechanical Jam; Insufficient Device Problem Information

  IT WAS REPORTED THAT THREE (3) INCISOR PLUS BL FROM THE SAME PACKAGE WERE NO LONGER FUNCTIONAL AFTER A SHORT TIME. AFTER THE BLADE WAS CONNECTED TO THE HANDPIECE IT DID NOT WORK. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY OR IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES, USING A SMITH AND NEPHEW BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19121919 ↗
• InjuryDec 11, 2020Break; Break

  IT WAS REPORTED THAT DURING A SURGERY, WHEN THE INCISOR BIADE ENTERED INTO THE PATIENT BODY, SOMETHING BRIGHT FELL OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A 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 10991263 ↗
• MalfunctionNov 26, 2019Flaked; Flaked

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY AND MENISECTOMY WHEN THE SURGEON WAS USING THE 4.5MM BLADE, METAL SHAVINGS WERE OBSERVED IN THE KNEE; THESE WERE REMOVED BY WASHING THEM OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES. 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 9373966 ↗
• MalfunctionNov 26, 2019Flaked; Flaked

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY AND MENISECTOMY, WHEN THE SURGEON WAS USING THE 4.5MM BLADE, METAL SHAVINGS WERE OBSERVED IN THE KNEE; THESE WERE REMOVED BY WASHING THEM OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES. 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 9373957 ↗
• MalfunctionAug 10, 2019Flaked; Flaked

  IT WAS REPORTED THAT DURING A SHOULDER CUFF REPAIR SURGERY, IT WAS FOUND THAT THE PLANER HEAD HAD DEBRIS FALLING OFF. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8881555 ↗
• MalfunctionJun 17, 2019Flaked; Flaked

  IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY, FRAGMENTS OF THE SHAVER WERE LEFT WITHIN THE PATIENT WHICH WERE UNABLE TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8705883 ↗
• MalfunctionAug 31, 2018Material Fragmentation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE TIP RELEASED FRAGMENTS. THE FRAGMENTS WERE REMOVED WITH THE CLAMP TWEEZER. NO PATIENT INJURY WAS REPORTED. BACK-UP DEVICE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7839633 ↗
• MalfunctionFeb 8, 2018Break

  IT WAS REPORTED THAT THE DSAVER BLADE BROKEN IN ROTATION IN THE JOINT DURING ASK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7251892 ↗