NA 7205317Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010251459), received between Sep 16, 2019 and Aug 24, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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

• MalfunctionAug 24, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADE HAD A FOREIGN MATTER OF BLACK COLOR ATTACHED WHEN THE PACKAGE WAS OPENED. THERE WAS NO DELAY IN THE CASE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. 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 10445902 ↗
• MalfunctionSep 16, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE WHEN THE DEVICE WAS SHAVING THE PLANNED FEMORAL BONE HOLE, IT WAS BENT AND BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9072869 ↗