NA 700357Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540413802), received between Jul 28, 2020 and Jul 28, 2020 — classified as 1 malfunction.

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

• MalfunctionJul 28, 2020Fracture; Fracture

  IT WAS REPORTED, WHEN USING THE JIGEN INSTRUMENT AT THE TIME OF TKA, THE SURGEON USED IT AS USUAL, AND WHEN HE CHECKED THE POST-OPERATIVE X-RAY, SOMETHING SIMILAR TO THE DRILL TIP WAS NOTED. IT WAS CONFIRMED THAT THE TIP OF THE 3.2 MM DRILL FOR JIGEN WAS BROKE; INVADING THE POSTERIOR CORTICAL BONE. TIP OF THE DRILL REMAINED INSIDE THE PATIENT' BODY. THE SURGEON'S OPINION: THE REASON FOR THE DAMAGE WAS BELIEVED TO BE METAL FATIGUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10334444 ↗