Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Medtronic Navigation, Inc. Sterile Percutaneous Reference Pin [Lot Numbers: 2023041134, 2023051138, 2022030438] [HKMD No.: 150408].
According to the TGA, the manufacturer has become aware that certain percutaneous pin lots have been identified as having a cross-pin that may render the percutaneous pin unable to fit into the tap cap, or too tight to remove the tap cap from the percutaneous pin once placed in the pelvis. This issue is associated with recently manufactured lots of the Percutaneous Pin used during spinal surgeries.
If this issue occurs, the user may be unable to remove a tap cap from the percutaneous pin. This could result in surgical delay, additional intervention for removal and replacement of percutaneous pin, or modification of the surgical approach using an alternative device.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-01055-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 Dec 2023