Events

Recall of DePuy Synthes Impactor for PFNA Blade

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

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-01638-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01638-1
  • 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
    Depuy synthes trauma has received product complaints for breakage in the pfna blade impactor, where the handle detached from the shaft of the instrument. it has been identified that a laser weld breakage, partial or complete, can occur in the pfna blade impactor where the handle detaches from the internal shaft of the instrument.In the event that the laser welding of the handle cracks, the handle may loosen or separate from the instrument. if the issue is detected during use, a marginal surgical delay may occur if the handle cracks, loosens, or separates. infection could potentially result if the handle is loosened from the shaft and allows body fluids (i.E. blood, bony debris) to enter the interior of the impactor’s handle.
  • Action
    Customers are advised to immediately quarantine the product and return it to JJM. If they have any questions about alternative devices, they are advised to contact DePuy Synthes Trauma.

Device

DePuy Synthes Impactor for PFNA Blade

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes