Alerta De Seguridad para Hexagonal Socket, Ø 4.0mm/11.0mm

Safety alert

2015-08-07

2015-08-07

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150807_b.html

Medical device safety alert: synthes gmbh hexagonal socket, ø 4.0mm/11.0mm medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its hexagonal socket, ø 4.0mm/11.0mm [part number: 356.714; lot number: all]. the manufacturer is initiating a voluntary medical device recall of the above mentioned part and lot numbers of the depuy synthes hexagonal socket, ø 4.0mm/11.0mm. the socket is a cannulated instrument used to insert the end caps in the following nail systems: proximal femoral nail anti-rotation (pfna), pfna-ii, and the antegrade femoral nail (afn). there is a potential for the socket-hex tip to break into fragments during use if too much force is applied. breakage of the hex tip may result in surgical delay and an adverse tissue reaction. as the affected item has been reported to break intra-operatively, there is potential for surgical delay while the fragments are retrieved. consequently, surgical delay may occur while a replacement instrument or alternative device is located to insert the end cap. in addition, an adverse tissue reaction may possibly occur if any stainless steel fragments from the socket are not retrieved from the patient. 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 07 august 2015.