NA 702926Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540401519), received between Dec 1, 2018 and Dec 1, 2018 — 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. 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.

• MalfunctionDec 1, 2018Break

  IT WAS REPORTED THAT THE TIP OF THE REPOSITIONING FORCEPS WAS BROKEN WHEN CRIMPING THE FRACTURE PART DURING OPERATION WITH VARIAX FIBULA. THEREFORE, IT WAS CHANGED THE NEW OTHER FORCEPS AND THE OPERATION WAS SUCCEEDED. THE SURGEON'S OPINION THAT THE BONE QUALITY OF THE PATIENT WAS GOOD AND THE FORCEPS WAS EXCESSIVE TWISTED. THE BROKEN PART WAS REMOVED AND IT WAS NOT LEFT IN THE PATIENT BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8122207 ↗