Events

Recall of Cranial Screw PlusDrive ø 1.6 mm, Self-Drilling, L 3mm (part of the Low Profile Neuro System intended for use in selective trauma of the midface and craniofacial skeleton)

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-00256-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00256-1
  • 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
    The affected part number and lot numbers are out of specification at the thread. this is related to a non-conformance where the thread height of these screws is under-sized. it was also identified that the cross section of the affected area is less than that of conforming screws such that the thread height of the screws is under-sized.The decreased thread height may alter the self-drilling feature and result in difficulty inserting the screw. if the surgeon finds that the screw is not inserting as anticipated, the surgeon may choose to use a different screw or drill a pilot hole to insert the screw. attempting to insert additional screws or possibly drill with another instrument could result in a surgical delay. should the user be able to insert the screw the decreased thread height may significantly reduce the retention ability of the screw in the bone. these issues may require medical or surgical intervention to secure components or stabilise the structure or bone.
  • Action
    Johnson & Johnson Medical (JJM) are advising users to remove and return all opened Titanium Low Profile Neuro Screw; Self- Drilling 3mm screws in stock, and to remove and return only affected lots of unopened screws in their original packaging. This action has been closed-out on 25/01/2017.

Device

Cranial Screw PlusDrive ø 1.6 mm, Self-Drilling, L 3mm (part of the Low Profile Neuro System inte...
  • Model / Serial
    Cranial Screw PlusDrive ø 1.6 mm, Self-Drilling, L 3mm (part of the Low Profile Neuro System intended for use in selective trauma of the midface and craniofacial skeleton)Part Number: 400.833Lot Numbers: 9951621, 9955377ARTG Number: 157068
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes