Intramedullary (SP 2 IM) Rod 400mm Instrument (surgical instrument used in both primary and revision P.F.C. SIGMA knee procedures) 의 리콜

Recall

RC-2015-RN-00956-1

Class II

2015-09-25

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00956-1

Complaints have been received 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 made with 455 ss alloy. there is a deep j-shaped groove at the tip of the rod, which allows a sleeve to lock into place when used in revision cases. it is within this groove that fracture can occur. if the affected sp2 im rod 400mm 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 rodif not 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 remodelling of bone and inflammation- pain due to potential bone remodelling or during magnetic resonance imaging (mri).

DePuy will be providing users with swap-out instruments as soon as possible to minimise any surgical disruption. In the meantime, medical professionals may opt to use the other size of the SP2 IM Rod: 300mm SP2 IM ROD (PN 96-6121). If a surgeon performed a procedure with an affected instrument and experienced a fractured instrument, the company recommends that surgeon users discuss potential clinical implications and risks with symptomatic patients. This action has been closed-out on 06/09/2016.