Events

Safety Alert Or Field Safety Notices for Nail intramedullary fixation system

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Zimmer Biomet.

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
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2017/025
  • Date
    2017-08-24
  • Event Date Posted
    2017-08-24
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/nail-intramedullary-fixation-system-trauma-guide-wires-70cm-risk-of-infection
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
    In June 2017 Zimmer Biomet issued a Field Safety Notice informing clinicians of the potential for a breach in the sterile barrier of affected devices. The trauma guide wires are intended to be used with the M/DN Femoral Interlocking and Recon Nail Intramedullary Fixation System.This Medical Device Alert is being issued to ensure that all hospitals are aware of the issue and that adequate action is taken to mitigate potential risk to patients.
  • Reason
    Manufactured by zimmer biomet – recall due to risk of infection if the wire breaks through the packaging (mda/2017/025).
  • Action
    Identify and quarantine all affected devices Return affected devices to the manufacturer Ensure that users are aware of the issues detailed in the manufacturer’s Field Safety Notice Complete the Field Safety Notice acknowledgement form and return to Zimmer Biomet. Report all adverse events involving this device to Zimmer Biomet and the MHRA or the appropriate Devolved Administration

Device

Nail intramedullary fixation system
  • Model / Serial
  • Product Description
    Extra information about the affected product list:Item number Device identifiers NHS Supply Chain code 00-2255-025-00 (01)00889024046467 FJU3054 00-2255-026-00 (01)00889024046474 FJU032 47-2255-008-00 (01)00889024085060 n/a 47-2490-098-00 (01)00889024094802 FQC20413 47-2490-098-01 (01)00889024094819 FQC20414
  • Manufacturer
    Zimmer Biomet

Manufacturer

Zimmer Biomet
  • Manufacturer Address
    Anne-Catherine Morancy Meister, Zimmer BiometTelephone: +41 58 854 82 37Email: anne.morancy@zimmerbiomet.com
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    MHRA