NA 5057-5-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327089653), received between Jan 28, 2022 and Jan 28, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (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 18, 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.

• MalfunctionJan 28, 2022Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "WHEN INSERTING IN THE MOTOR A 5 MM FICHE DIAMETER OF THE HOFFMAN 3 IN ITS OWN GUIDE (THEY VERIFIED THAT THE GUIDE WAS THE CORRECT ONE FOR THE 5 MM DIAMETER), AFTER ABOUT 10 SECONDS THE SURGEON REPORTED AN OVERHEATING AND A BLOCKAGE OF THE FICHE IN THE GUIDE, AS IF A ¿MERGER¿ HAS HAPPENED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13388692 ↗