Alerta De Seguridad para INSTRUMENTS PFC AND SPECIALIST (Instrument Intramedullary Specialist 2 (SP 2 IM) 400mm (PN 96-6120)) - Registration No. 10132590285 - Lot: C4GA54, Lot: TBAGG, Lot: H0302, Lot: H0401, Lot: H0610, Lot : H0710, Lot: H0810, Lot: H1008, Lot: H0999

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The company informs that if the affected 400mm (SP 96-6120) IM SP2 Rod Tool breaks during surgery and a portion of the rod stays in the patient, the possible clinical implications are: • If observed during surgery: - Significant delay in surgery due to the attempt to remove the remaining stem; - Minor bone damage due to attempted removal of the remaining rod. • If not observed during surgery: - An adverse reaction may occur because the fractured shaft, if not removed from inside the bone, can act as a stressor causing bone remodeling and inflammation; - Pain during possible bone remodeling or during Magnetic Resonance Imaging (MRI) exams. DePuy does not recommend a prophylactic review in the absence of symptoms. If a surgeon performed a procedure using an affected instrument and it broke, the company recommends that the surgeon discuss the potential clinical implications and risks with symptomatic patients. Sharing this information will allow surgeons to discuss the problem and provide follow-up recommendations.