Medical device manufacturer, Synthes GmbH, has issued a medical device safety alert concerning its Small Electric Drive [Part number: 05.001.175; Lot number: All].
According to the manufacturer, it has been reported that the Small Electric Drive (SED) may experience failure modes such as the device not functioning, the device operating solely in reverse mode, the device not operating in reverse when intended or an unintended start of the device.
If the device is tested in the operative theatre and the unit does not function, a replacement power tool would need to be procured, which may lead to surgical delay.
An unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue damage, peripheral nerve damage and or vascular damage because the hand piece has the potential to progress further into the surgical site when the operator is not intending this motion. These injuries may need surgical or medical intervention.
The manufacturer instructs affected users to immediately identify and quarantine all unused products.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 December 2014