Events

Bone Screws 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Synthes 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
    2013-08-21
  • 사례 출판 날짜
    2013-08-21
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130821.html
  • 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 bone screws medical device manufacturer, synthes, has initiated a product recall of certain bone screws. the affected part numbers are 04.019.030; 04.019.038; 04.019.040; 04.019.042; 04.019.046; 04.019.054; 412.105; 412.118; 413.012; 413.016; 413.018; 413.022; 413.024; 413.026; 413.028; 413.040s; 413.044s; 413.052; 413.070s; 413.314; 413.326; 413.330; 413.330s; 413.332; 413.332s; 413.334; 413.336; 413.338; 413.338s; 413.340; 413.340s; 413.342; 413.344; 413.350s; 413.355s; 413.360; 413.360s; 413.365; 413.375; 413.380; 413.385; 413.414; 413.465 and 422.396-us. synthes received a complaint by a surgeon that a multiloc screw with a deformed cross-hole was identified in the loan office. the root cause is related to an employee failed to follow established processes. the manufacturer explains that the presence of a screw that is out of specification may be detected prior to insertion. in this situation it is likely that the surgical delay would be minimal while an alternative screw is located and inserted. the screw may also be difficult to insert and/remove due to the non-conformance. if the screw was inserted and the non-conformance was detected after implantation, a surgical delay may result, during removal, exposing the patient to increased amounts of anesthesia and iv fluids. one the other hand, if the non-conforming screw is not detected by the surgeon and the index procedure is completed, there is the potential that the screw will not perform as anticipated during the post-operative recovery period. the non-conforming screw has a smaller outer diameter, hence there is an increased risk of screw loosening and backout in this scenario. this can result in prolonged healing, pain, and the need for an additional surgical intervention. permanent impairment is not anticipated. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 21 august 2013.

Device

Bone Screws
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Synthes Bone Screws
  • Manufacturer
    Synthes

Manufacturer

Synthes