Events

Safety Alert for RIA System (Reamer / Irrigator / Aspirator)

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Synthes Gmbh.

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
    R1611-489
  • Event Number
    2012DM-0008758
  • Date
    2016-10-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=118
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer has determined that the wraps for the milling wands are delaminated, which hinders the opening of the sterile wrapping and could be experienced contact non-sterile surfaces contaminating them, a situation that would lead to possible adverse events on the patients.

Device

RIA System (Reamer / Irrigator / Aspirator)
  • Model / Serial
    milling rod for SynReam 2.5 mm, length: 650 mm, sterile, reference 351.709S, lots || specific.
  • Product Description
    The RIA system (strawberry / irrigator / aspirator) is indicated for intramedullary milling and for the extraction of bone tissue, which cleans the medullary canal of bone marrow and debris. It is also used to clean the infected bone marrow canal, efficiently determine the size of the medullary canal for the acceptance of an implant or intramedullary prosthesis. RIA works by extracting autogenous bone tissue, finely morselized and bone marrow for any surgical intervention that requires a graft of bone tissue in order to facilitate fusion or fill bone defects. These interventions may be spinal fusion, joint arthrodesis, total joint replacement, fracture repair, absence of fracture consolidation, maxillofacial reconstruction, and tumor removal.
  • Manufacturer
    Synthes Gmbh

Manufacturer

Synthes Gmbh