Medical device manufacturer, Synthes, has issued a medical device safety alert concerning its Mandible Distractor, Monoaxial and Proximal Foot Plate.
According to the manufacturer, the fastener on the Mandible Distractor may become prematurely separated from the Proximal Foot Plate.
In the event that the Mandible Distractor becomes disengaged from the Proximal Foot Plate during device implantation, surgical delay may occur if another device is not available in the surgical suite. If the Mandible Distractor becomes disengaged from the Proximal Foot Plate after device implantation, repeat surgery may be required to replace the Mandible Distractor/Foot Plates. There may be a risk of local infection as a result of repeat surgery caused by the disengagement since the product is in the oral cavity.
There is no replacement device available from the manufacturer. The manufacturer offers several alternative devices which are also intended for distraction of the mandible, including the Stainless Steel Mandible Distractor System, the Titanium Multi-Vector Distractor module System, and the Curvilinear Distraction System.
According to the local supplier, the following affected products are distributed in Hong Kong:-.
A) Mandible Distractor, monoaxial, left, distraction length 30mm [Part number: 487.965, Lot number: 6538904]
B) Proximal Foot Plate, left, f/Mandib. Distractor, monoaxial [Part number: 487.975, Lot number: 7865426]
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 June 2016