Events

Reamer/Irrigator/Aspirator (RIA)(Medullary canal orthopaedic reamer, flexible) 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-00618-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00618-1
  • 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
    Depuysynthes reported that the ria drive shaft, tube assembly, and reamer head have the potential to break when incorrectly assembled or used improperly as follows: - failure to fully engage the reamer to shaft at assembly prior to surgery. incorrect assembly creates a reduced reamer/shaft contact surface area, in which excess rotational forces could cause breakage- use of ria drive shafts after the flats have become worn and rounded - use of any excess force beyond design limit - use with an incompatible power tool. precautionary statements are being added to the reamer / irrigator / aspirator (ria) surgical technique guide.
  • 조치
    DePuySynthes is requesting the customers to download the updated Surgical Technique Guide (036.000.553). from Synthes website at:- http://syntheskyo.com/global_trauma_kyo/home/home.htm or contact their DePuy Synthes Representative for a hardcopy. This action has been closed-out on 05/12/2016.

Device

Reamer/Irrigator/Aspirator (RIA)(Medullary canal orthopaedic reamer, flexible)
  • 모델명 / 제조번호(시리얼번호)
    Reamer/Irrigator/Aspirator (RIA)(Medullary canal orthopaedic reamer, flexible)Model number: 036.000.553Multiple Part NumbersARTG Numbers: 153666 and 157016
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes