Implantable screw: MatrixMANDIBLE, MatrixNEURO, MatrixMlDFACE and MatrixORTHOGNATHlCS - incorrectly etched screw size

(Synthes GmbH) Could lead to clinical complications including dural injury, bleeding and failure of fracture fixation. (MDA/2013/044)

CAS deadlines

Action underway: 4 July 2013, action complete: 11 July 2013

Note: These deadlines are for systems to be in place to take actions and not for the completion of patient follow-up.

Device

Implantable screw

Implantable screw: MatrixMANDIBLE, MatrixNEURO, MatrixMlDFACE and MatrixORTHOGNATHlCS.

Manufactured by Synthes GmbH.

Specific lot numbers affected. 

The affected screws were first distributed in July 2007.  Each screw is held within a clip that has a number etched on it, corresponding to the length of the screw.

Problem

Recall due to incorrectly etched screw size on the screw-holding clip (see picture).

The use of an incorrectly sized screw could lead to clinical complications including dural injury, bleeding and failure of fracture fixation.

The manufacturer has received reports of instances where the number etched on the screw holder does not match the length of the screw. This includes screws being labelled as being longer or shorter than they actually are. However, the outer packaging of the device has the correct screw size.

The use of an incorrectly sized MatrixMANDIBLE, MatrixMlDFACE and MatrixORTHOGNATHlCS screw could lead to inadequate fixation or loss of fixation.

The use of an incorrectly sized MatrixNEURO screw may result in a life threatening event for patients at greatest risk. If the screw is too long, the greatest risks are posed to paediatric patients, patients with skull deformities, and patients with face lesions because they are predisposed to having skulls that may not be as thick as the largest available screw (5mm). If a screw is longer than anticipated it may come into contact with the patient’s dura and small vessels.

The manufacturer has recalled these devices and will be offering an alternative.

Action

  • Identify and quarantine any unimplanted affected devices using the list of lot numbers in the manufacturer’s Field Safety Notice (FSN)
  • Return unused affected devices to the manufacturer.
  • If there are no alternatives and you need to use the affected screws you should confirm the length of the screw prior to use by measuring it on the measuring scale provided on the case.

The manufacturer advises that patients who have had procedures using the Synthes CMF Matrix Screws should be followed up using standard diagnostic evaluation and treatment protocols. If the follow-up reveals risk to vessels or dura, the potential for inadequate fixation or potential loss of fixation due to incorrect screw length, standard diagnostic evaluation and treatment protocols for these types of events should be followed.

Action by

  • Neurosurgeons
  • Oral / maxillofacial surgeons
  • Ophthalmic surgeons
  • Paediatric surgeons
  • Plastic surgeons
  • Supplies managers
  • Sterile services managers
  • Theatre managers

Distribution

This MDA has been sent to:  

  • Care Quality Commission (CQC) (headquarters) for information
  • Clinical commissioning groups (CCGs)
  • HSC trusts in Northern Ireland (chief executives)
  • Local authorities in Scotland (equipment coordinators)
  • NHS boards and trusts in Wales (chief executives)
  • NHS boards in Scotland (equipment coordinators)
  • NHS trusts in England (chief executives)

Onward distribution

Please bring this notice to the attention of relevant employees in your establishment. 
Below is a suggested list of recipients.  

Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • Neurosurgeons
  • Oral / maxillofacial surgeons
  • Ophthalmic surgeons
  • Paediatric surgeons
  • Plastic surgeons
  • Risk managers
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres
  • Sterile services

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

  • Hospitals in the independent sector
  • Independent treatment centres

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.

Manufacturer contact

Manufacturer

Synthes GmbH
Luzernstrasse 21
CH-4528
Zuchwil
Switzerland
Tel: +41 32 720 72 24            
Fax: +41 79 345 96 93   

                
Email: allemann.claudia@synthes.com

Feedback

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/044 or 2013/004/019/291/014.

Technical aspects

John McManus or Salma Husain
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7226 / 6729
Fax: 020 8754 3965

Email:  john.mcmanus@mhra.gsi.gov.uk or salma.husain@mhra.gsi.gov.uk

Clinical aspects

Carol Lowry or Kayleigh Purdon
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7248 / 7032
Fax: 020 8754 3965

Email:  carol.lowry@mhra.gsi.gov.uk or kayleigh.purdon@mhra.gsi.gov.uk

How to report adverse incidents

Please report via our website: Reporting adverse incidents involving medical devices
Further information about CAS can be found on the CAS website

Northern Ireland

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald BT4 3SQ
Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website
Further information about SABS can be found on the SABS 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
Gyle Square
1 South Gyle Crescent
Edinburgh EH12 9EB
Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC)

Wales

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ
Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk

Download documents

Medical Device Alert: Implantable screw: MatrixMANDIBLE, MatrixNEURO, MatrixMlDFACE and MatrixORTHOGNATHlCS manufactured by Synthes GmbH (MDA/2013/044) (94Kb)

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