Trochanteric Fixation Nail Advanced (TFNA) guide sleeve, yellow 의 안전성 경고

Safety alert

2016-06-24

2016-06-24

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160624b.html

Medical device safety alert: depuy synthes trochanteric fixation nail advanced (tfna) guide sleeve, yellow medical device manufacturer, depuy synthes, has issued a field safety notice (fsn) concerning its trochanteric fixation nail advanced (tfna) guide sleeve, yellow. the affected part number is 03.037.017. the manufacturer has identified that the some lots of the guide sleeves may have been manufactured with a slightly larger than specified outer diameter which could prevent the sleeve from going through the tfna aiming arm properly. only guide sleeves that do not pass function testing will be removed from the field following the evaluation for functionality of the aiming arms and guide sleeve described in the fsn. in the event that guide sleeve does not fit through the tfna aiming arm properly, a surgical delay may occur. the manufacturer is advising users to take the following actions: to review the inventory to identify and quarantine all affected products in a manner that ensures the affected products will not be used. conduct functional testing and ensure every aiming arm is tested with every guide sleeve within the user’s control. return any affected product that does not pass functional testing to the manufacturer. according to the local supplier, johnson and johnson, two lots of the affected product (lot numbers: 9066435, 9356941) are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 june 2016.