Frangible Tag Bone Screw for FDA Traceability
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Solution Overview
Problem
Small medical implants like bone screws face challenges in incorporating FDA-mandated traceability information due to limited surface area, requiring additional tags that increase manufacturing costs and complexity, especially since every surface of a bone screw performs critical functions.
Innovation Solution
A bone screw design featuring a frangible interface allows for an integral tag body to be formed as an extension of the screw body, which can be removed after implantation, providing space for traceability information without compromising the screw's functionality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If a separately attachable tag is used to provide traceability information, then the traceability information can be displayed, but the manufacturing cost and process complexity increase
Solution Approach 1:
The tag body is merged with the screw body to form an integral structure, eliminating the need for separate attachment steps. The tag body extends from the screw body as a unified component formed through the same manufacturing process, thereby reducing manufacturing complexity while maintaining traceability information display capability.
2Loss of information
If a separately attachable tag is used to provide traceability information, then the traceability information can be displayed, but additional manufacturing costs are incurred
Solution Approach 1:
The tag body and screw body are manufactured as a single integrated component using the same material and forming process. This merging eliminates the need for separate tag production, material selection, and attachment operations, thereby reducing manufacturing costs while ensuring traceability information is adequately displayed.
3Device complexity
If the tag is formed integrally with the screw body, then manufacturing steps are reduced, but the tag must be removable after implantation
Solution Approach 1:
The integral structure is segmented into a screw body and a tag body through a frangible interface. This interface is designed with reduced material thickness or structural weakness that allows the tag body to be cleanly separated from the screw body after implantation, maintaining manufacturing simplicity while enabling post-implantation tag removal.
Solution Approach 2:
The frangible interface is pre-designed during manufacturing with specific geometric features (such as reduced thickness regions or predetermined fracture planes) that facilitate easy separation. This preliminary preparation ensures that the tag can be removed after implantation without requiring complex removal tools or procedures.
4Reliability
If every surface of the bone screw performs critical functions, then the screw's functionality is optimized, but there is no available surface area for traceability information
Solution Approach 1:
The tag body extends from the screw body in a direction perpendicular to the functional surfaces of the screw. By utilizing this additional dimensional space, the traceability information can be displayed without interfering with or reducing the functionality of the screw's critical surfaces.
Solution Approach 2:
The screw device is segmented into the functional screw body and the separate tag body. The tag body serves exclusively for traceability information display, while the screw body maintains all critical functional surfaces for bone engagement and fixation, thereby resolving the conflict between functionality and information display requirements.
Data Source
AI summary
An implant in the form of a bone screw that meets device tracking requirements set for the in the FDA regulations is provided. The bone screw includes a screw body and a tag body formed as an integral extension of the screw body and is connected to the screw body via a frangible interface bone screw. The screw body has a head portion and a threaded shaft portion that extends along a longitudinal axis from the head portion to a screw tip of the screw body. The tag body defines at least one surface configured to display traceability information for the bone screw. The frangible interface is disposed between the tag body and the screw tip of the screw body. The frangible interface is configured to fracture upon application of a predefined mechanical force so that the tag body is removable from the bone screw.