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.
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.
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.
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.
Oral / maxillofacial surgeons
Sterile services managers
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)
Please bring this notice to the attention of relevant employees in your establishment.
Below is a suggested list of recipients.
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
Oral / maxillofacial surgeons
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: email@example.com and requesting this facility.