Events

Field Safety Notices about Reamer/lrrigator/Aspirator (RIA)

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Synthes GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2015-07-01
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Precautionary statements are being added to the “reamer/ lrrigator / aspirator (ria) surgical technique guide". it was reported that the ria drive shaft, tube assembly, and reamer head have the potential to break when incorrectly assembled or used improperly.

Device

Reamer/lrrigator/Aspirator (RIA)
  • Model / Serial
    RIA Drive Shaft, length 360 mm 314.742 RIA Drive Shaft, length 520 mm 314.743 RIA Tube Assembly, for RIA Drive Shaft 314 7458 minimum length 360 mm. for No. 314.742. sterile ' RIA Tube Assembly, for RIA Drive Shaft 314 7468 minimum length 520 mm. for No. 314.743, sterile ‘ RIA Medullary Reamer Head 0 12.0 mm, sterile 352.2508 RIA Medullary Reamer Head i3 12.5 mm, sterile 352.2518 RIA Medullary Reamer Head D 13.0 mm, sterile 352.2528 RIA Medullary Reamer Head I2 13.5 mm, sterile 352.2538 RIA Medullary Reamer Head 9 14.0 mm. sterile 352.2548 RIA Medullary Reamer Head 0 14.5 mm, sterile 352.2558 RIA Medullary Reamer Head 9 15.0 mm. sterile 352.2568 RIA Medullary Reamer Head 2 15.5 mm. sterile 352.2578 RIA Medullary Reamer Head 0 16.0 mm, sterile 352.2588 RIA Medullary Reamer Head (3 16.5 mm. sterile 352.2598 RIA Medullary Reamer Head (25 17.0 mm. sterile 352.2618 RIA Medullary Reamer Head 9 17.5 mm. sterile 352.2628 RIA Medullary Reamer Head 0 18.0 mm. sterile 352.2638 RIA Medullary Reamer Head 0 18.5 mm, sterile 352.2648 RIA Medullary Reamer Head D 19.0 mm, sterile 352.2658
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH