REDUCTION TOOL 0804-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848665002607), received between Jul 24, 2024 and Jul 24, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 24, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 06/28/2024, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT A 0804-000 REDUCTION TOOL WAS BENT. THE SURGEON NOTICED THAT THE REDUCTION TOOL THEY WERE USING TO CHANGE THE POSITION OF THE BALL TIP WIRE WAS BENT AND SHOULD REMAIN STRAIGHT AND NOT BE EASY TO BEND IN THE SHAFT. THE REPRESENTATIVE STATED THAT THIS IS AN EXTENSIVE MANUAL FOR SURGEONS TO USE INTRAMEDULLARY, AND ANY BEND IN POOR BONE COULD CAUSE AN IATROGENIC FRACTURE. NO HARM CAME TO THE PATIENT; THEY CHANGED INSTRUMENTS WHEN THEY NOTICED THE DEFICIENCY IN THE PRODUCT. THIS WAS DISCOVERED DURING A HIP FRACTURE PROCEDURE (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818654 ↗