Knee Instruments 02.07.10.1040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040758154), received between Apr 10, 2019 and Oct 9, 2020 — classified as 2 injuries.

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

• InjuryOct 9, 2020Crack

  DURING THE TIBIAL PREPARATION IN THE PRIMARY KNEE SURGERY, THE SURGEON CRACKED THE TIBIA WITH THE TIBIAL PUNCHER. THE SURGEON USED CABLES AROUND THE TIBIA TO PREVENT THE PROPAGATION OF THE FRACTURE. THERE WAS A 5-MINUTES DELAY IN THE SURGERY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A LOANER SET WAS UTILIZED.

  Patient problems: Bone Fracture(s)

  MAUDE report 10654568 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem

  DURING TIBIAL KEEL PREPARATION A TIBIAL PLATEAU FRACTURE HAS OCCURRED, DESCRIBED AS VERTICAL PATTERN OF FRACTURE FROM POSTERIOR CORTEX TO ANTERIOR ONE. TREATED WITH 2 SCREWS FIXATION AND TIBIAL STEM. THE SURGEON THINKS THAT THIS IS COMBINATION OF SCLEROTIC BONE AND BLUNT PUNCHER.

  Patient problems: Bone Fracture(s)

  MAUDE report 8498766 ↗