Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by MATHYS.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 005 10 13 000
  • Event Initiated Date
    2013-10-01
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=4438
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
  • Extra notes in the data
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Mathys ltd bettlach (mathys) has been notified of an incident in where the optimys opening broach broke intraoperatively and the fragment was left in the bone. investigations have shown that the instrument was not used in compliance with the instructions, and detailed exploration revealed that this was causal to the incident. in the course of the investigations, it became apparent that the opening broach bent may exhibit surface defects in the hewn portion which may favor breakage in case of non-compliant usage.

Device

Bone rasp , optimys Opening Broach bent
  • Model / Serial
    Article number: 51.34.0079 Lot numbers: 6053731, 6054883, 6057918, 6059150, 6060683
  • Product Description
    Orthopaedic surgery tools , Bone rasp , optimys Opening Broach bent
  • Manufacturer
    MATHYS

Manufacturer

MATHYS