Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00795-1
Product Name/Description	Medtronic Midas Rex Sagittal Saws (used with the Medtronic Integrated Power Console (IPC) System) Saw Sagittal Item Number: ES300 Saw Sagittal, Refurbished Item Number: ES300-R Saw Sagittal, Finger Item Number: ES310 Saw Sagittal, Finger, Refurbished Item Number: ES310-R All Serial Numbers affected ARTG Number: 200336
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/06/2016
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	This action is being taken to mitigate the risk of injury associated with the potential for leakage of fluid into the motor through the Rocker Housing Seal. The Seal is intended to prevent ingress of fluid into the Sagittal Microsaws during use and decontamination. Although there have been no reports of fluid leakage occurring in the field, engineering testing of the seal identified the potential for leakage to occur. In assessing the risk of this potential failure, testing was conducted that indicated the gravity displacement sterilisation cycle which is included in the IPC User Manual may not be adequate to ensure sterility of internal motor components if fluid ingress occurs beyond the Rocker Housing Seal. In the event that fluid leaks into the motor through the Rocker Housing Seal, and gravity displacement sterilisation method is used, if fluid leaks from the motor during use and this fluid contacts the patient surgical site, there is a potential for infection to occur.
Recall Action	Recall
Recall Action Instructions	Customers are advised to check their inventory for the affected products. A Medtronic Representative will be in touch with customers to organise the return of this product. This action has been closed-out on 17/02/2017.
Contact Information	02 9857 9243 - Medtronic