Drill Bit and Adjustable Drill Stop 의 안전성 경고

Safety alert

2012-09-03

2012-09-03

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120903.html

Medical device safety alert: synthes drill bit and adjustable drill stop it has come to our attention that medical device manufacturer, synthes, has issued a medical device safety alert concerning drill bit 2.5mm complete, 2-flute (part no. 03.613.010); 2.5 mm drill bit, graduated 12mm-26mm adjustable depth (part no. 03.613.011); and adjustable drill stop (part no. 03.613.012). according to the manufacturer, a recall of the vectra system graduated 2.5mm drill bit and the adjustable drill stop has been initiated. although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event. if the drill stop slips on the drill bit, it could result in the penetration of the posterior cortex, dural tear requiring repair, damage to the spinal cord, quadriplegia, and the risk of a potentially life-threatening event. the manufacturer advised users to stop using the affected products and not to utilize self-tapping screws (20-26mm) in the absence of this drill bit assembly. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 3 september 2012.