| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01278-1 |
| Product Name/Description |
Synthes Small Electric Drive Hand Piece (Drill Surgical System)
Part Number: 05.001.175
All Lot Numbers
ARTG Number: 157072 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
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. This may lead to surgical delays in the event the user requires a replacement power tool. 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. |
| Recall Action |
Recall |
| Recall Action Instructions |
Affected units are to be quarantined and returned as per the instructions in the Customer Letter. DuPuy Synthes will then provide a replacement at no charge in the form of a Colibri II (532.101) along with an electric adapter (05.001.1058) and a wire driver (532.022) to use instead of the Small Electric Drive. This action has been closed-out on 06/07/2016. |
| Contact Information |
1800 796 8437 - Synthes Australia Pty Ltd |