Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; DEPUY INTERNATIONAL LTD.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1734
  • Date
    2015-11-13
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    The company received complaints regarding affected batches, stating that the stem broke and a portion of the stem was left in the patient. all complaints involve the 400 mm im sp2 rod tool (pn 96-6120) made of 455 ss alloy. the company identified the failure potential of the 400 mm haste im sp2 instrument, manufactured with 455 ss alloy, due to fatigue and / or overloading by applying excessive leverage to the 400 mm shank im sp2 instrument (pn 96-6120).
  • Action
    DePuy directs that the affected batches of the 400mm Haste IM SP2 IM Instruments (PN 96-6120) be immediately discontinued. i) identify if they have any of the instruments involved in this field action and return the affected instruments immediately; ii) Kits containing 400mm Rods SP 400 Instruments (PN 96-6120) include: - SIGMA SP2 Primary Instrument Sets, - SIGMA HP Primary Instrument Sets, - PFC Sigma TC3 Revision Instrument Sets. Refer to the "Instrument Options" section of the Letter to the Customer (Appendix II) for alternatives to the 400mm Rod Tool IM SP2 (PN 96-6120). -16)

Device

INSTRUMENTS PFC AND SPECIALIST (Instrument Intramedullary Specialist 2 (SP 2 IM) 400mm (PN 96-612...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; DEPUY INTERNATIONAL LTD