Events

Medtronic Navigated Solera Driver Tips for Spinal Surgery, Instrument set or kit models numbers (which contains the drivers) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia Pty Ltd 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-00925-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-09-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00925-1
  • 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
    Complaints have been received by medtronic related to broken, bent or damaged screwdriver tips. under certain use conditions, the torque required to fully seat a pedicle screw may be higher than the screwdriver tip can withstand. those conditions include: • the hole for the screw not drilled to the proper diameter • the hole for the screw not tapped adequately, either in the diameter or the length • dense bone • large diameter screws the screwdriver tip breaking could result in the extension of the surgery due to the need to find a replacement screwdriver, and if broken, extract the broken tip from the screw to complete the insertion, or the removal of the tip from the patient.
  • 조치
    Medtronic is modifying the instructions for use (IFU) for the navigated screwdrivers to add additional warnings related to the careful inspection of the instruments regularly for damage and the importance of knowledge of the operating procedures, patient selection, and product information. The revised IFUs will be included with all new navigated screwdrivers. Some images of conditions to look for during inspection is included in the customer letter. Revised IFUs will be also provided with the customer letter. This action has been closed-out on 19/08/2016.

Device

Medtronic Navigated Solera Driver Tips for Spinal Surgery, Instrument set or kit models numbers (...
  • 모델명 / 제조번호(시리얼번호)
    Medtronic Navigated Solera Driver Tips for Spinal SurgeryModel numbers: 9735023, 9735024, 9735025, 9735026, 9735027, 9734856, 9734857, 9734279, 9734373 Instrument set or kit models numbers (which contains the drivers) - 9735283, 9735283-G02, 9734632, 9734647, 9734648, 9735281, 9735278, 9735282, 9735279, 9735280 All serial numbersARTG Numbers: 119952 and 120114
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA