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Manufactured by Synthes GmbH – Recall due to risk of infection from cracked weld of the handle.
NOTE: These deadlines are for systems to be in place to take actions and not for the completion of patient follow-up.
All lots of the DePuy Synthes Impactor for PFNA Blade (P/N 03.010.410) are affected.
In December 2016 DePuy Synthes issued a Field Safety Notice (FSN) informing clinicians of the possibility of breakage of the PFNA Blade impactor handle. If the breakage goes unnoticed, any body fluids that get into the handle during use would pose a risk of cross-contamination to other patients.
The manufacturer sent a second Field Safety Notice in April 2017 to hospitals that hadn’t replied to the first FSN.
MHRA is issuing this Medical Device Alert to ensure that all hospitals are aware of the problem and that adequate action is taken to mitigate risks to patients.
Jody Cadd Field Action Manager Depuy Synthes GmbH Luzernstrasse 21 Zuchwil 4528 Switzerland
Email: RA-ITSUS-JJMUK_FA-SS@its.jnj.com
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
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.
Send enquiries about this notice to MHRA, quoting reference number MDA/2017/022 or 2016/012/012/291/031.
Jacques Pouget or Michelle Kelly, MHRA
Email: jacques.pouget@mhra.gov.uk or michelle.kelly@mhra.gov.uk
Email: dct@mhra.gov.uk
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
Email: niaic@health-ni.gov.uk
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
Email: nss.iric@nhs.net
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, Welsh Government
Email: Haz-Aic@wales.gsi.gov.uk
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
DePuy Synthes Impactor for PFNA (Proximal Femoral Nail Anti-rotation) Blade (MDA/2017/022)
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