INSTRUMENT I-K2218FP00Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327316223), received between Feb 26, 2021 and Feb 26, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 18, 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.

• MalfunctionFeb 26, 2021Fracture; Fracture

  PART #: I-K2218FP00 2 PINS WERE USED IN A TOTAL KNEE. THEY WERE DRILLED INTO THE PATIENT USING A WIRE DRIVER AND UPON REMOVING THE WIRE DRIVER THE END OF THE PINS BROKE OFF. NOTHING WAS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11389375 ↗
• MalfunctionFeb 26, 2021Fracture; Fracture

  PART #: I-K2218FP00. 2 PINS WERE USED IN A TOTAL KNEE. THEY WERE DRILLED INTO THE PATIENT USING A WIRE DRIVER AND UPON REMOVING THE WIRE DRIVER THE END OF THE PINS BROKE OFF. NOTHING WAS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11389314 ↗