Events

Recall of Beaver 4.0mm Banana Blade

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00093-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00093-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    A number of customer complaints have been received indicating that during arthroscopic hip surgery the blades are experiencing brittle fracture.In the event the instrument breaks, the failure is visually obvious to the user and the broken blade can be retrieved. in a rare instance the device could break and fall into surgical site or joint space, making it difficult to retrieve. this can potentially cause a surgical delay. it has also been reported that in rare cases the broken blade remained in the patient.
  • Action
    Smith & Nephew is advising users to immediately discontinue the use of the affected units prior to their quarantine and return.

Device

Beaver 4.0mm Banana Blade
  • Model / Serial
    Beaver 4.0mm Banana BladeModel Number: 72203307Various Batch Numbers affectedARTG Number: 140406
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd