NA 7205459Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010252234), received between Mar 17, 2020 and Feb 9, 2025 — classified as 2 injuries, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING A ROTATOR CUFF TENDON PROCEDURE, THE INCISOR PLUS DETACHED A LOT OF METAL PARTICLES. ALL FRAGMENTS WERE REMOVED FORM THE PATIENT. 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 21341253 ↗
• InjurySep 26, 2023Flaked; Flaked

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, METAL SHARDS FROM THE INCISOR PLUS BLADE WERE FOUND IN PATIENT'S SHOULDER. SUCTION WAS USED TO REMOVE THE METAL SHARDS, MINOR SHARDS WERE LEFT BEHIND. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 17818827 ↗
• InjuryJul 26, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, METALLIC MICROPARTICLES WERE FOUND INSIDE THE JOINT CAUSED BY THE INCISOR PLUS SHAVER BLADE; THE PARTICLES WERE ASPIRATED ALONG WITH THE SERUM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108884 ↗
• MalfunctionMar 17, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING SURGERY, AFTER STARTING TO USE BURR, FINE METAL SHAVINGS WERE SEEN IN THE JOINT. THE JOINT WAS FLUSHED AND APPEARED TO NOT HAVE BEEN LEFT ANY PIECES INSIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY 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 Known Impact Or Consequence To Patient

  MAUDE report 9840486 ↗