NA 7205331Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010251596), received between Nov 21, 2017 and Jun 30, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY, IT WAS FOUND THAT THE BLADE HAD METAL ABRASION. ALL THE MATERIAL WAS VACUUMED FROM THE PATIENT'S ANATOMY. NO SIGNIFICANT DELAY WAS REPORTED AND THE SURGERY WAS FINISHED USING A SMITH AND NEPHEW 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: Injury

  MAUDE report 10212187 ↗
• MalfunctionNov 21, 2017Peeled/Delaminated

  IT WAS REPORTED THAT THE BLADE WAS SHEDDING DURING THE PROCEDURE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7051511 ↗
• MalfunctionNov 21, 2017Peeled/Delaminated

  IT WAS REPORTED THAT THE BLADE WAS SHEDDING DURING THE PROCEDURE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7051507 ↗