Epoca Stem Extractors and Connection Screws 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Synthes GmbH 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2018-03-28
  • 사례 출판 날짜
    2018-03-28
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: synthes gmbh epoca stem extractors and connection screws medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its epoca stem extractors and connection screws. the affected devices are identified as follow: - stem extractor f/guide bar part number: 03.401.072; lot numbers: 09-6793, 10-2637, 10-5070, 12-2707, 14-1085, 15-8949 screw m6x18 part number: 03.401.077; lot number: 10-4566 the manufacturer is initiating a voluntary field safety notification (fsn) for the part and lot numbers of the epoca stem extractors and connection screws. there is a potential for the connection screw (p/n 03.401.077) of the stem extractor (p/n 03.401.072) to break. this breakage could occur during the step 3 “head/eccenter removal and humeral stem extraction” shown and described on page 10 of the surgical technique “epoca revision set” [dsem/trm/0714/0131(1)]. “to remove the stem, mount and fully tighten the stem extractor using the hexagonal wrench. mount the ram/guide bar and apply gentle blows.” according to the manufacturer, if the stem extractor breaks, the potential impact to the patient includes surgical delay, bone damage, and/or adverse tissue reaction. the affected users are asked to review the instructions listed in the fsn. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 march 2018.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Synthes GmbH Epoca Stem Extractors and Connection Screws
  • Manufacturer

Manufacturer