Categorization of Adverse Events Reported to the FDA Pertaining to Tibia Intramedullary Nailing.

Abstract

OpenFDA is an open access database maintained by the United States Food and Drug Administration (FDA) that we queried for adverse events (AEs) related to product devices used during tibia intramedullary nailing (IMN) procedures. There was a total of 1,799 reports pertaining to tibial intramedullary nailing from 1996 to 2020. Causes included infection (451), nonunion (380), intraoperative issue (343), painful hardware (234), implant fracture (195), other (68), loosening (35), surgeon error (24), packing problem (24), patient injury (12), expiration (12), contamination (11) and allergic reaction (10). The total number of events increased in 2016 and 2018, which was attributed to 510k approval for Stryker. Of the Aes, 1,400 resulted in an injury to the patient. In total, 78% occurred in the post-operative period, and 68% required additional surgery. Most incidents related to tibia IMNs result in injury and require additional surgery. When new products are released, AEs occur quickly and in bulk. (Journal of Surgical Orthopaedic Advances 31(4):237-241, 2022).