Smith & Nephew(SNN) - 2021 Q4 - Annual Report

Product Safety and Compliance - In 2021, Smith+Nephew reported 13 product recalls globally, impacting a total of 23,832 units[1645] - Smith+Nephew received 2 Form 483s from the FDA in 2021, with no warning letters or seizures reported[1645] - The FDA's MedWatch database is used to report product safety alerts and recalls[1645] - The company reported no fatalities related to products as per FDA requirements[1645] - All impacted products from recalls were either removed from the market or corrected per applicable regulations[1645] - Smith+Nephew emphasizes compliance with current Good Manufacturing Practices (cGMP) in its operations[1645] - All direct and third-party manufacturing locations of Smith+Nephew are certified to ISO13485, ensuring product quality and compliance[1646] Ethical Practices and Governance - Smith+Nephew's code of ethics governs the promotion of off-label use of products, detailed in their Code of Conduct[1645] - The company emphasizes the importance of maintaining a code of ethics governing interactions with healthcare professionals[1648] - Smith+Nephew did not incur any monetary losses due to legal proceedings associated with bribery or corruption in 2021[1648] - Smith+Nephew's financial statements reflect a commitment to transparency and compliance with international financial reporting standards[1650] - The independent registered public accounting firm KPMG LLP has provided consent, indicating ongoing external oversight of financial reporting[1671] - Certifications from key executives were filed, reinforcing accountability and governance standards within the organization[1671] Sustainability Initiatives - Smith+Nephew's sustainability report includes information on ethical marketing practices[1645] - The company tracks regulatory changes regarding chemicals in products and incorporates sustainability reviews in the New Product Development phase[1646] - Smith+Nephew's sustainability targets and strategy are detailed in their 2021 Sustainability Report[1647] - The company emphasizes the use of renewable, biodegradable inks that emit fewer Volatile Organic Compounds (VOCs) compared to traditional inks, aligning with sustainability goals[164] - The company has implemented takeback schemes for products where required by law, although it does not measure the amount of products reused or recycled for business purposes[1646] Financial Reporting and Structure - Smith & Nephew plc reported a total amount of securities exceeding 10% of its total assets on a consolidated basis, indicating significant leverage in its capital structure[1668] - The company has not issued any long-term debt instruments that would exceed the 10% threshold of total assets, reflecting a conservative approach to debt management[1668] - Smith & Nephew plc is committed to providing the SEC with copies of any instruments defining the rights of holders of its long-term debt upon request, ensuring transparency[1668] - The company has a history of various agreements and contracts, including a material contract for a merger dated March 12, 2019, which indicates ongoing strategic initiatives[1668] - The company has filed its Annual Report on Form 20-F, certifying compliance with all filing requirements[1674] Corporate Events and Reporting - Smith+Nephew's Annual General Meeting (AGM) is scheduled for April 13, 2022, at 2:00 PM, with electronic participation options available for shareholders[159]. - The first quarter Trading Report will be released on April 28, 2022, followed by the payment of the 2021 final dividend on May 11, 2022[163]. - The half-year results will be announced on July 28, 2022, and the third quarter Trading Report is set for November 3, 2022[163]. - The Global Share Plan 2020 was filed, indicating a focus on employee engagement and retention through equity participation[1671] Operational Risks and Supply Chain - Smith+Nephew's supply chain risks are identified as Principal Risks within its Enterprise Risk Management process[1646] - The company maintains traceability in its distribution chain through Unique Device Identifiers or HIBC barcodes[1646] - The company has a diverse range of principal subsidiaries, which may enhance its market reach and operational capabilities[1671] Financial Data Presentation - The Inline XBRL Instance Document contains embedded XBRL tags for financial data presentation[1673] - The XBRL Taxonomy Extension Schema Document is included for detailed financial reporting[1673] - The XBRL Taxonomy Extension Calculation Linkbase Document is provided for calculation definitions[1673] - The XBRL Taxonomy Extension Label Linkbase Document is available for labeling financial data[1673] - The XBRL Taxonomy Extension Presentation Linkbase Document is included for presentation formats[1673] - The XBRL Taxonomy Extension Definition Linkbase Document is provided for definitions of financial terms[1673] - The Cover Page Interactive Data File is formatted as Inline XBRL and contained in Exhibit 101[1673]