Knee Instruments 11.00009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030842740), received between Apr 18, 2019 and Dec 13, 2021 — classified as 2 malfunctions.

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. 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.

• MalfunctionDec 13, 2021Break; Break

  WHEN THE PIN WAS INSERTED TO FIX THE CUTTING BLOCK IT BROKE AT THE CONNECTION LEVEL WITH THE PIN ADAPTER. THE SURGEON USED A BACKUP CUTTING BLOCK AND PIN AND THE SURGERY WAS COMPLETED SUCCESSFULLY. DELAY TIME 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12982546 ↗
• MalfunctionApr 18, 2019Fracture; Fracture

  DURING THE FIXATION OF A TIBIAL RECUT JIG, INE OF THE LONG THREADED PINS BROKE AND REMAINED IN THE PATIENT DURING SURGERY. FLUOROSCOPY WAS DONE INTRA-OPERATIVELY TO IDENTIFY THE LOCATION OF THE BROKEN INSTRUMENT IN ORDER TO REMOVE IT, BUT THE SURGEON WAS NOT ABLE TO REMOVE IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8527548 ↗