FDA WARNING_LETTER - Hand Biomechanics Lab Inc - July 05, 2017

On November 16, 2017, the FDA issued a Warning Letter to Hand Biomechanics Lab, Inc. following an inspection from June 22 to July 5, 2017. The firm manufactures bone fixation fastener systems, classified as medical devices.

The inspection revealed two primary areas of violation:

1. **Medical Device Reporting (MDR) Violations:** The devices were deemed misbranded due to the firm's failure to furnish required information under Section 502(t)(2) of the Act and 21 CFR Part 803. * **Failure to Submit MDRs:** The firm failed to submit reports within 30 days for events where their Digit Widget device may have caused or contributed to serious injuries (e.g., pin site infections requiring medical intervention), specifically citing complaints C060416, C110116, C061915, C030117, and C091115. The firm's July 24, 2017 response was inadequate as it lacked information on their decision-making process for not reporting these events. * **Inadequate MDR Procedures (21 CFR 803.17):** The firm's "MDR Submissions SOP046, 114-011" procedure lacked: