Events

DePuy Synthes Impactor for PFNA Blade 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-01638-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-12-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01638-1
  • 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
    Depuy synthes trauma has received product complaints for breakage in the pfna blade impactor, where the handle detached from the shaft of the instrument. it has been identified that a laser weld breakage, partial or complete, can occur in the pfna blade impactor where the handle detaches from the internal shaft of the instrument.In the event that the laser welding of the handle cracks, the handle may loosen or separate from the instrument. if the issue is detected during use, a marginal surgical delay may occur if the handle cracks, loosens, or separates. infection could potentially result if the handle is loosened from the shaft and allows body fluids (i.E. blood, bony debris) to enter the interior of the impactor’s handle.
  • 조치
    Customers are advised to immediately quarantine the product and return it to JJM. If they have any questions about alternative devices, they are advised to contact DePuy Synthes Trauma.

Device

DePuy Synthes Impactor for PFNA Blade

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes