NA 72201513Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010654458), received between Jun 4, 2018 and Jun 13, 2024 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Flaked” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CMC ARTHROSCOPY, THE HEAD/TIP OF THE INCISOR PLUS BLADE CAME OFF INSIDE THE JOINT SPACE OF THE PATIENT. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT WITH ARTHROSCOPIC GRASPER/FORCEPS. 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 19533046 ↗
• InjuryMar 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT AT THE BEGINNING OF AN ARTHROSCOPY PROCEDURE, THE SPECIALIST ENTERED THE 2.9 MOTOR TERMINAL THROUGH THE WORK PORT AND IT WORKED NORMALLY, LATER HE CHANGED THE INSTRUMENT IN SAID PORT AND WHEN HE WANTED TO USE THE INCISOR PLUS AGAIN IT NO LONGER WORKED, HE REQUESTED TO CHECK THE DEVICE AND WHEN DISASSEMBLING IT WAS FOUND THAT THE INTERNAL PART OF THE DEVICE WAS FRACTURED. IT DID BROKE INSIDE, HOWEVER, NO PARTS WERE LEFT INSIDE THE PATIENT. UNFORTUNATELY THERE WAS ONLY ONE KIT AND THERE WAS NO WAY TO SOLVE IT, SO THEY PERFORMED OPEN SURGERY AND VISUALIZED THE JOINT SPORADICALLY WITH ARTHROSCOPY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521898 ↗
• InjuryNov 28, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE INCISOR PLUS BLADE CREATED METAL FLAKE. THE MATERIAL WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15871841 ↗
• InjuryNov 27, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING A WRIST SCOPE SURGERY THE PLUS ELITE BLADE WAS RELEASING METAL SHARDS, ALL THE PIECES WERE SUCTIONED OUT FROM THE PATIENT'S ANATOMY. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. NO DELAY 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10913833 ↗
• MalfunctionMar 1, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY THE BLADE WAS MAKING BLACK POWDER WHEN IT WAS USED. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 9772692 ↗
• MalfunctionMar 1, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY THE BLADE WAS MAKING BLACK POWDER WHEN IT WAS USED. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 9772690 ↗
• MalfunctionFeb 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY PROCEDURE, THE DEVICE BROKEN OFF INSIDE THE PATIENT. HOWEVER, THE PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES 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 9748366 ↗
• MalfunctionJun 4, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT A PIECE OF THE BLADE BROKE OFF IN THE PATIENT. ALL PIECES WERE REMOVED. THERE WAS NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7566008 ↗