Knee Instruments 02.07.10.4048Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040760119), received between Sep 27, 2024 and Sep 27, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2024Use of Device Problem; Use of Device Problem

  WHEN USING THE CROSSOVER INSTRUMENTATION, IT WAS NOTICED THAT THE REAMERS IN THE SLEEVES DO NOT HAVE PROPER GUIDANCE AS SOON AS THEY ARE INSERTED INTO THE SHAFT AND TEND TO DEVIATE. THIS CREATED PROBLEMS WHEN PLACING THE TRIALS AND THE FINAL IMPLANTS. THE SURGEON FIRST USED SAFE GUIDING REAMER Ø11MM, THEN SAFE GUIDING REAMER Ø13MM, ANF INALLY SAFE GUIDING REAMER Ø16MM. THE OPERATION TIME WAS EXTENDED BY ABOUT AN HOUR AND MORE ANESTHETIC HAD TO BE ADMINISTERED. ON THE TIBIA, THE TIBIA WAS INITIALLY NOT PLACED CLEANLY ON THE RESECTION BECAUSE THE SHAFT WAS DIVERTED. THE FEMUR WAS FLEXED AND HAD NO SECURE HOLD BY THE SHAFT. THIS HAD TO BE HELD IN PLACE FOR CEMENTATION, OTHERWISE IT WOULD NOT HAVE REMAINED IN THE CORRECT POSITION. NO DEFECTS CAN BE NOTED ON THE REAMERS. THE PATIENT WAS VERY YOUNG AND HAD HARD BONES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320103 ↗