HOFFMANN 4922-2-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540681027), received between Feb 18, 2020 and Feb 18, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 18, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE ATTACHMENTS COULD NOT BE ATTACHED. REPLACEMENT DEVICES WERE AVAILABLE. ADDITIONALLY REPORTED: THE ATTACHMENT COULD NOT BE PUT INTO THE 5-HOLE PIN HOLDER. THE APPROACHES DID NOT FIT INTO THE "STAR BORE" PROVIDED FOR THEM. THE ORIGINAL H3 7MM T-WRENCHES TO LOOSEN THE SCREWS DURING TESTING WERE USED. THE CUSTOMER NOTICED THE PROBLEMS ALREADY WHEN CONNECTING THE PIN HOLDER WITH THE ATTACHMENTS, SO NO FURTHER ASSEMBLY WAS MADE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9721687 ↗