Device Dossier

Expert Tibial Nail PROtect - Tibia intramedullary nail

Device Dossier for Expert Tibial Nail PROtect - Tibia intramedullary nail (Tibia intramedullary nail, Class III, sponsor DePuy Synthes). ARTG record,…

Intended purpose

Depuy Synthes EXPERT Tibial Nail PROtect is intended for temporary fixation, correction and stabilization of bones in the tibia.

Functional description

is an intramedullary (IM) nail that consists of a Ti-6Al-7Nb IM nail, which is coated with a fully resorbable poly(D,L-lactide) (PDLLA) coating, in which particles of the antibiotic Gentamicin sulfate are embedded. The purpose of the resorbable coating with antibiotic is to prevent bacterial colonization on the implant upon implantation and in the following days.it is identical to the uncoated nail in all issues relating to fracture treatment.

TGA Public Summary