Events

TFN-ADVANCED Proximal Femoral Nailing System (TFNA) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2015-RN-00372-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-05-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00372-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    Johnson & johnson is initiating a recall for product correction for the depuy synthes tfn-advanced proximal femoral nailing system (tfna). the tfna system is intended for treatment of proximal femoral fractures.There is the potential that the tfna nails received before march 31, 2015 from the affected lots were assembled with a locking mechanism too close to the top of the nail. this problem was due to human error during assembly of the device with the manufacturer and no design changes are required.Therefore locking mechanism could:· prevent the connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the insertion handle, or· cause the bottom of the connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism.The above may lead to delays in surgery with the potential for complications associated with prolonged anaesthesia.
  • 조치
    A workaround is being provided for users via the customer letter. This action has been closed-out on 08/08/2016.

Device

TFN-ADVANCED Proximal Femoral Nailing System (TFNA)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes