NA 013550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010024985), received between Jan 7, 2020 and Sep 12, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Cut” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE TENDON STRIPPER COULDN'T CUT THE GRAFT AT THE MOMENT OF REMOVAL AND ANOTHER INCISION WAS NECESSARY TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS A 30 MINUTES SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation

  MAUDE report 17733389 ↗
• MalfunctionJan 7, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT, DURING A ACL CLANCY PROCEDURE, THE SURGEON STATED THAT THE TENDON STRIPPER WAS NOT CUTTING THROUGH TISSUE. THE PROCEDURE WAS COMPLETED WITH A TENDON STRIPPER FROM ARTHREX. THERE WAS A DELAY BETWEEN 5-10 MINUTES. NO PATIENT INJURY WAS 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 9560416 ↗