Knee Instruments 11.01024Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030878565), received between Jul 14, 2017 and Jul 14, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJul 14, 2017Break; Break

  WHEN SURGEON WAS USING THE TIBIAL KEEL PUNCH THE KEEL BROKE. PER THE SURGEON THE PATIENT HAD HARD BONE. NO FRAGMENTS FELL INTO THE PATIENT. THE SURGEON USED A METAL KEEL OUT OF ANOTHER SET. THERE WAS A DELAY OF LESS THAN 5 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY INSTRUMENTATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6714196 ↗