MHRA Issues Medical Alert For DePuy Synthes Trauma External Fixation System

Instructions For Products Have Been Corrected

24.07.2014

The Medical and Healthcare Regulatory Agency (MHRA) has issued a medical alert related to Synthes trauma external fixation system manufactured by DePuy Synthes.

Instructions for the devices, which are used in the treatment for some broken bones, have been amended by the manufacturer to ensure the devices now classed as ‘MR Conditional’. 

This classification places additional restrictions on patient positioning and a failure to alter the instructions could result in patient harm. Concerns have arisen that improper use could cause the devices to increase in temperature, causing a thermal injury to soft tissue, or bone damage.

Medical professionals have been instructed to ensure all DePuy Synthes external fixation products etched ‘MR-Safe’ are now considered as MR-Conditional and used in accordance with the updated MR-Conditional labelling.

DePuy Synthes has issued a field safety notice (FSN) for the products affected by the medical alert, which is an extension of a previous FSN from the company in April for the same devices.

Expert Opinion
Patient care is always a top priority and this latest medical alert is clear confirmation that manufacturers need to ensure the instructions for these specific devices are accurate and reflect safe usage guidelines before they are introduced to the market.

“All of those involved in the field of medicine have a duty to act when medical device alerts of this nature are issued. We would also urge the manufacturer to ensure steps are taken in the manufacturing process to prevent these safety concerns from having to be repeated.

“It is particularly worrying in this case that another issue has arisen with products linked to DePuy. We currently represent people affected by problems in relation to the firm’s ASR and Pinnacle metal-on-metal hip implants, as well as Adept implants manufactured by Finsbury Orthopaedics – a subsidiary of DePuy.

“It is vital the company takes action to prevent further issues with its products in the future.”
Kevin Timms, Solicitor