- 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
- 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
Extra information about the affected product list:
||NHS Supply Chain code
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.
Anne-Catherine Morancy Meister,
Telephone: +41 58 854 82 37
Telephone: 0165 667 4270
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
- Orthopaedic surgeons
- Risk managers
- Supplies managers
- Theatre managers
- Theatre nurses
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: firstname.lastname@example.org and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2017/025 or 2017/006/020/291/001.
Mr Hasan Samee-Ahmed or Miss Feza Haque, MHRA
Tel: 020 3080 6807 or 020 3080 7066
Email: email@example.com or firstname.lastname@example.org
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Reporting adverse incidents in England
Through Yellow Card
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
Northern Ireland Adverse Incident Centre (NIAIC)
Please report directly to NIAIC using the forms on our website.
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
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.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).