Orthopaedic bone plates and cortical screws: ADVANSYS MLP-DLP; ADVANSYS TTC; Large QWIX; TIBIAXYS and UNI-CP–Sterile – Risk of infection (MDA/2018/028)

Manufactured by Newdeal SAS – Risk of infection from compromised packaging.

Action

1.Identify and quarantine all affected devices. 2. Locate and return affected devices to Smith & Nephew as detailed in the Field Safety Notice. 3 Complete the certificate of acknowledgement attached to the Field Safety Notice and return it to the manufacturer. 4. Report adverse events involving these devices to your local incident reporting system, the manufacturer, and your national incident reporting authority: England, Scotland, Northern Ireland, Wales.

Action by

All users of the affected medical device.

Deadlines for actions

Actions underway: 15 August 2018

Actions complete: 29 August 2018

Medical Device Safety Officers (in England)

Ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.

Remember

If your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.

Device details

The affected devices are used in various bone and joint reconstruction procedures.

In addition to the Field Safety Notice which details affected product, please refer to the spreadsheet below which accompanies this MDA for additional unique device identification information.

Problem/background

In May 2018, Newdeal SAS, a company within Integra LifeSciences Group, issued a Field Safety Notice informing distributors and clinicians of devices possibly affected with defective packaging. This defect may result in insufficient sealing, a potential consequence of which is an increased risk of infection.

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.

Manufacturer contacts

Newdeal SAS
Tel: +33 (0)4 37 47 51 51
Fax/telecopy: +33 (0)4 37 47 59 30

emea-fsca-recon@integralife.com or marilyse.latour@integralife.com

Distribution

If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.

Trusts (NHS boards in Scotland)

CAS and NICAS liaison officers for onward distribution to all relevant staff including:

  • Orthopaedic surgeons
  • Sterile services departments
  • Supplies managers
  • Theatre managers
  • Theatres

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

  • Hospitals in the independent sector
  • Independent treatment centres

Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@mhra.gov.uk and requesting this facility.

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2018/028 or 2018/005/025/291/009.

Technical aspects

Hasan Samee-Ahmed, MHRA
Tel: 020 3080 6807

Email: hasan.samee-ahmed@mhra.gov.uk

Clinical aspects

Devices Clinical Team, MHRA

Tel: 020 3080 7274

Email: dct@mhra.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

Alerts in Northern Ireland are distributed via the NICAS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety

Tel: 028 9052 3868

Email: niaic@health-ni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)

Please report directly to NIAIC using the forms on our website.

Scotland

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland

Tel: 0131 275 7575

Email: nss.iric@nhs.net

Reporting adverse incidents in Scotland

NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.

Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.

Private facilities providing care to private clients report to the Care Inspectorate and MHRA.

Wales

Enquiries in Wales should be addressed to:

Healthcare Quality Division,
Welsh Government

Tel: 02920 823 624 / 02920 825 510

Email: Haz-Aic@wales.gsi.gov.uk

Reporting adverse incidents in Wales

Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

Download documents

MDA 2018-028

UDI GSI Device and Header Spreadsheet

Published 1 August 2018