Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument 의 안전성 경고

Safety alert

2015-09-16

2015-09-16

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150916c.html

Medical device safety alert: depuy synthes specialist 2 intramedullary (sp2 im) rod 400mm instrument medical device manufacturer, johnson and johnson, has issued a field safety notice concerning its specialist 2 intramedullary (sp2 im) rod 400mm instrument. the affected part number (pn) is 96-6120. the manufacturer has received complaints which state that the rod fractured and a portion of the rod was left in the patient. all of the complaints involved the sp2 im rod 400mm instrument (pn 96‐6120) made with 455 ss alloy. the manufacturer has identified the potential for the instrument (pn 96‐6120) made with 455 ss alloy to fail due to fatigue and/or overload when excess leverage is applied to it. in addition, the instruments (pn 96‐6120) made from 17-4 ss, distributed between may 1995 and february 2001, are also included in this notice to retrieve any instruments remaining in the market. according to the manufacturer, if the affected instrument fractures during surgery and a portion of the rod is left in the patient, the possible clinical implications are: if observed during surgery: significant surgical delay due to attempted retrieval of remaining rod minor bone damage due to attempted retrieval of remaining rod if observed during surgery: adverse tissue reaction may occur because the fractured rod, if not removed from within the bone, can act as a stress riser causing remodeling of bone and inflammation pain due to potential bone remodeling or during magnetic resonance imaging (mri) the clinical implications above may potentially require revision surgery. the manufacturer advises users to cease using the affected lots of the instruments (pn 96‐6120) immediately. replacement of the affected instruments will be provided. according to the local supplier, the affected instruments are distributed in hong kong. kits containing the instruments (pn 96‐6120) include: pfc sigma sp2 primary instrument sets sigma hp primary instrument sets pfc sigma tc3 revision instrument sets if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 september 2015.