Reflection® dead blow mallet (all batches) – risk of exposure to lead particles

Manufactured by Smith & Nephew – cracking of the welds on the head of the mallet can result in lead particles escaping and entering the surgical wound, potentially resulting in effects associated with lead exposure.

Action

  • Be aware of the manufacturer’s Field Safety Notice
  • Locate and quarantine all batches immediately
  • Return quarantined product to the manufacturer
  • Complete the return slip as requested by the manufacturer
  • Contact the manufacturer to arrange for an alternative device

Action by

All those who use these devices.

Deadlines for actions

Actions underway: 3 March 2017

Actions complete: 31 March 2017

Manufacturer contacts

Greg Williams
Smith & Nephew
Tel: 01480 423 200

Email greg.williams@smith-nephew.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:

  • A&E departments
  • Biomedical engineering staff
  • Day surgery units
  • General surgeons
  • General surgery
  • General surgical units, directors of
  • Health and safety managers
  • Orthopaedic surgeons
  • Purchasing managers
  • Risk managers
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres

Public Health England

Directors for onward distribution

  • Safety officers

Independent distribution

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

  • Hospitals in the independent sector

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/2017/002 or 2016/011/018/701/004.

Technical aspects

Mariam Ali or Sara Vincent, MHRA

Tel: Tel: 020 3080 6877 / 020 3080 7169

Email: mariam.ali@mhra.gsi.gov.uk or sara.vincent@mhra.gsi.gov.uk

Clinical aspects

MHRA Devices Clinical Team

Tel: 020 3080 7274

Email: DCT@mhra.gsi.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

Alerts in Northern Ireland are distributed via the NI SABS 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

Web: www.health-ni.gov.uk/niaic

Reporting adverse incidents in Northern Ireland

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/2017/002

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