Events

Recall of Drill Sleeve 9.0/2.8, L 191 mm, f/AFN (used with the Antegrade Femoral Nail System to hold and guide implants and instruments during orthopaedic surgery)

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-00257-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00257-1
  • 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
    It has been identified that the specified affected lots of the drill sleeve may not couple with the protection sleeve (part number 356.705) due to the potential for interference between these two devices. in the event that the drill sleeve would not couple with the protection sleeve, a surgical delay would likely occur as the situation is assessed and the next steps are determined. if a drill sleeve is not used, the accuracy of insertion of the guide wire and/or proximal locking screw could potentially be reduced and may potentially result in damage to surrounding structures or a mal-union/non-union requiring a re-operation.The guide sleeve also provides mechanical support of the wire. thus, if the sleeve is not used, the potential exists for guide wire breakage and an adverse tissue reaction if the entire guide wire is not removed despite the guide wire being implant grade.
  • Action
    Johnson & Johnson Medical (JJM) is advising users to quarantine all affected stock and return.

Device

Drill Sleeve 9.0/2.8, L 191 mm, f/AFN (used with the Antegrade Femoral Nail System to hold and gu...
  • Model / Serial
    Drill Sleeve 9.0/2.8, L 191 mm, f/AFN (used with the Antegrade Femoral Nail System to hold and guide implants and instruments during orthopaedic surgery)Part Number: 356.706Multiple Lot Numbers affectedARTG Number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes