Locking Compression Plate Drill Sleeve 1.5 f/Drill Bit ø1.1mm 의 안전성 경고

Safety alert

2017-08-15

2017-08-15

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170815.html

Medical device safety alert: synthes gmbh locking compression plate drill sleeve 1.5 f/drill bit ø1.1mm medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its locking compression plate (lcp) drill sleeve 1.5 f/drill bit ø1.1mm. [part number: 03.114.001; lot numbers: 9972971, h028400, h161606, h288454]. the manufacturer is initiating a voluntary field safety notification for the above lots of the lcp drill sleeve which is part of the 1.5 mm lcp modular mini fragment system. the lcp compact hand 1.5 implants are intended for temporary fixation, correction or stabilization of bones in anatomical region of the hand. drill/protection guide/sleeves are intended for holding and guiding implants and instruments during orthopaedic surgery. according to the manufacturer, there may be difficulty attaching the affected lots of the drill sleeve to the plate. if the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. additionally, if the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening. affected users are not required to return the synthes lcp drill sleeves. they are advised to pre-assemble the drill sleeve with the plate preoperatively. if they experience difficulty connecting the drill sleeve to the plate, they should use the additional 1.1 mm locking drill sleeve provided in the graphic case, or: align the 1.1 mm drill bit to the plate as perpendicular as possible and then drill freehand and the locking screw can be engaged in this manner. if the drill hole must be used and no option to lock remains, a non-locking screw can be used. 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 15 august 2017.