Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.
Medical devices distributed, prior to sterilization
Medical devices distributed, prior to sterilization
Medical devices distributed, prior to sterilization
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
Due to Titanium plasma coating not present implant.
Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.
It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery.
Missing drill guide as stated in the package.