Events

Connecting Screw for Insertion of Dynamic Hip Screw (DHS) Blade(Component of the fixation system implantation kit) 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-00358-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-04-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00358-1
  • 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
    Complaints of the insertion screw breaking inside the blade implant during insertion. when the dhs blade connecting screw breaks inside the implant, it blocks the locking mechanism that is important for rotational stability (ensuring the bone fragments maintain anatomical reduction). in the event that the tip of the connecting screw breaks intraoperatively, the implant locking mechanism (for rotational stability) cannot be secured.If the fragment cannot be retrieved, rotational stability is compromised and the blade needs to be replaced or additional lag screws implanted. this may lead to prolongation of surgical operating time, bone damage and subsequent interventions such as a total hip arthroplasty. if the fragment cannot be retrieved and remains in the dhs blade in the patient, this could lead to an adverse tissue reaction since the connecting screw is not made of implant grade stainless steel.
  • 조치
    Johnson & Johnson Medical Pty Limited (JJM) is requesting the customers to check the inventory and quarantine the affected stock prior to returning it to JJM. This action has been closed-out on 24/08/2016.

Device

Connecting Screw for Insertion of Dynamic Hip Screw (DHS) Blade(Component of the fixation system ...
  • 모델명 / 제조번호(시리얼번호)
    Connecting Screw for Insertion of Dynamic Hip Screw (DHS) Blade(Component of the fixation system implantation kit)Part Number: 03.224.007Lot Numbers: 2161305, 2290282, 2523116, 2684005, 7799873, 8296913, 8586241, 9001624, 2243635, 2290283, 2557362, 2733243, 7799873, 8465206, 8694982, 9290024, 2260851, 2512219, 2561953, 2762808, 8037035, 8487190, 8759606, 2260851-I, 2290278, 2513675, 2630618, 2800137, 8117808, 8577396, 8889838, 2260851-L.ARTG number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes