Events

Aiming Arm 125deg and Aiming Arm 130deg for TFN-ADVANCED (TFNA) System(Orthopaedic surgical guide) 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-00216-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00216-1
  • 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
    It was discovered that during blade insertion, the tfna guide sleeve has the potential to jam inside of the affected aiming arms which may delay disassembly and/or removal of the instruments.
  • 조치
    Johnson & Johnson Pty Limited is providing end users with work around instructions to be used until replacement stock is available. In the event that the user has difficulty with the Aiming Arm/Guide Sleeve Assembly the user can disassemble via two methods: 1) Turn the Guide Sleeve counter clockwise within the Aiming Arm to clear the jamming. This operation can be performed manually and requires relatively low force and no additional instrumentation. 2) Disassemble the Aiming Arm/Guide Sleeve assembly as one unit by disengaging the Aiming Arm coupling screw from the Insertion Handle. The instruments can then be disassembled for cleaning using the technique described in 1). Johnson & Johnson Pty Limited will provide replacement product by 1 May 2015. This action has been closed-out on 17/08/2016.

Device

Aiming Arm 125deg and Aiming Arm 130deg for TFN-ADVANCED (TFNA) System(Orthopaedic surgical guide)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes