- Medicines and Healthcare products Regulatory Agency
- 17 August 2017
- 17 August 2017
- Alert type:
- Medical device alert
- Medical specialty:
- Anaesthetics, Cardiology, Care home staff, Cosmetic surgery, Critical care Dentistry, General practice, General surgery, Haematology and oncology, Infection prevention, Obstetrics and gynaecology, Ophthalmology, Orthopaedics, Paediatrics, Pathology, Pharmacy, Physiotherapy and occupational therapy, Radiology, Renal medicine, Theatre practitioners, Urology, and Vascular and cardiac surgery
Manufactured by Synthes GmbH – Recall due to risk of infection from cracked weld of the handle.
- Review your inventory to identify affected products
- Refer to the manufacturer’s Field Safety Notice (dated April 2017) for alternative devices to use
- Report all adverse events involving this device to DePuy Synthes 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: 01 September 2017
Actions complete: 15 September 2017
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.
Problem / background
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.
Field Action Manager
Depuy Synthes GmbH
Telephone: +41 32 720 4933
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 consultants
- A&E departments
- A&E directors
- A&E nurses
- Equipment stores
- Fracture clinics
- General surgeons
- General surgery
- General surgical units, directors of
- Orthopaedic surgeons
- Sterile services departments
- Supplies managers
- Theatre managers
- Theatre nurses
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: email@example.com 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
Tel: 020 3080 6143 or 020 3080 7145
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Reporting adverse incidents in England
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
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.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Published: 17 August 2017
Issued: 17 August 2017
Alert type: Medical device alert
Medical specialty: Anaesthetics Cardiology Care home staff Cosmetic surgery Critical care Dentistry General practice General surgery Haematology and oncology Infection prevention Obstetrics and gynaecology Ophthalmology Orthopaedics Paediatrics Pathology Pharmacy Physiotherapy and occupational therapy Radiology Renal medicine Theatre practitioners Urology Vascular and cardiac surgery