HOFFMANN 4933-9-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613252611035), received between Apr 8, 2024 and Apr 8, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 9, 2024Open, Classified

   The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.

   Z-2219-2024 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2024Break; Fracture; Use of Device Problem; Break; Fracture; Use of Device Problem

  AS REPORTED: " DURING THE CLEANING AND STERILIZATION , INSTRUMENT HAS BEEN BROKEN. DO NOT KNOW WHAT HAPPENED, BUT PARTS DO NOT FIT LIKE THEY HAVE DONE BEFORE. THEY HAVE USED CLEANING PROTOCOL ADVICE WE HAVE IN WRITING (IFU). NO HARM IN OPERATION WHEN USED, ONLY IN CLEANING PROCESS HAVE NOTICED BROKEN DEVICE. NO PATIENT HARM OR DELAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067470 ↗
• MalfunctionApr 8, 2024Use of Device Problem; Use of Device Problem

  IT IS REPORTED THAT THE PRODUCTS WOULD NOT SHOW HOW MUCH TRACTION WAS BEING PUT THROUGH (POSSIBLE MISSING PART).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067342 ↗
• MalfunctionApr 8, 2024Use of Device Problem; Use of Device Problem

  IT IS REPORTED THAT THE PRODUCTS WOULD NOT SHOW HOW MUCH TRACTION WAS BEING PUT THROUGH (POSSIBLE MISSING PART).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067316 ↗
• MalfunctionApr 8, 2024Use of Device Problem; Use of Device Problem

  IT IS REPORTED THAT THE PRODUCTS WOULD NOT SHOW HOW MUCH TRACTION WAS BEING PUT THROUGH (POSSIBLE MISSING PART).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067118 ↗
• MalfunctionApr 8, 2024Use of Device Problem; Use of Device Problem

  IT IS REPORTED THAT THE PRODUCTS WOULD NOT SHOW HOW MUCH TRACTION WAS BEING PUT THROUGH (POSSIBLE MISSING PART).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19066951 ↗