FDA WARNING_LETTER - LockDown Medical Ltd. - June 05, 2014

On June 2-5, 2014, the FDA inspected LockDown Medical Ltd. in Redditch, UK, and found that their Surgicraft LockDown Acromioclavicular Device was misbranded and had quality system deficiencies.

Violations included: 1. **Failure to report device malfunctions (MDRs):** The firm did not submit MDRs for two malfunction complaints (b)(6) and (b)(6) for their long-term implant, the Surgicraft LockDown Acromioclavicular Device, within 30 days, as required by 21 CFR 803.50(a)(2). The firm's response stating they would submit these MDRs by June 30, 2014, was deemed inadequate as the reports were not received. 2. **Failure to develop, maintain, and implement written MDR procedures:** The "Incident Reporting Procedure," SOP (b)(4), Issue No. (b)(4), lacked an effective date, definitions of reportable events (e.g., "become aware," "serious injury"), a standardized review process for reportability, instructions for complete investigations, clear assignment of reporting decisions, and guidance for timely transmission of complete MDRs (e.g., FDA 3500A form, reporting circumstances). It also failed to address documentation and record-keeping requirements for MDR event files and decision-making processes, and