Events

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) 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-2016-RN-00257-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00257-1
  • 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 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.
  • 조치
    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...
  • 모델명 / 제조번호(시리얼번호)
    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