Nail intramedullary fixation system: Trauma guide wires 70cm – risk of infection

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

Action by

  • Medical directors
  • Orthopaedic departments
  • Orthopaedic and trauma surgeons
  • Staff involved in the management of trauma patients

Deadlines for actions

Actions underway: 08 September 2017

Actions complete: 25 September 2017

Device details

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

Problem / background

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.

Manufacturer contacts

Anne-Catherine Morancy Meister,
Zimmer Biomet

Telephone: +41 58 854 82 37

Email: anne.morancy@zimmerbiomet.com

UK contact:

Peter Bevan
Zimmer Biomet

Telephone: 0165 667 4270

Email: fieldaction.uk@zimmerbiomet.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 SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • Equipment stores
  • Microbiologists
  • Orthopaedic surgeons
  • Risk managers
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres

Independent distribution

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

  • Hospitals in the independent sector
  • Independent treatment centres
  • Nursing agencies
  • Private medical practitioners

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@dh.gsi.gov.uk and requesting this facility.

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2017/025 or 2017/006/020/291/001.

Technical aspects

Mr Hasan Samee-Ahmed or Miss Feza Haque, MHRA

Tel: 020 3080 6807 or 020 3080 7066

Email: hasan.samee-ahmed@mhra.gov.uk or feza.haque@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

Fax: 0131 314 0722

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 document

MDA/2017/025, Nail intramedullary fixation system: Trauma guide wires 70cm – risk of infection

Published 24 August 2017