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Journal of Orthopaedics and Traumatology

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Open Access 01-12-2021 | Original article

Bent or broken: analysis of set screw fracture in the TFNa implant

Author: Matthew Klima

Published in: Journal of Orthopaedics and Traumatology | Issue 1/2021

Abstract

Objectives

To evaluate set screw fracture in the Trochanteric Femoral Nail Advanced implant (TFNa, Synthes, West Chester, PA) and to identify additional mechanisms of set screw failure in the TFNa.

Materials and methods

Patients who had experienced failure after open reduction and internal fixation (ORIF) with the TFNa were identified. TFNa implants were explanted and inspected following revision surgery. Medical device reports (MDRs) and manufacturer’s inspection reports describing similar failures for the TFNa in the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database were also reviewed.

Results

Four set screw fractures that occurred at a level II trauma center were observed. Sixty-seven reported failures were identified in the MAUDE database for review. Twenty-eight failed implants were returned to the manufacturer for inspection with a published inspection report available for analysis. Set screw fractures can occur in the TFNa when the set screw is deployed prematurely into the proximal screw aperture prior to blade/screw insertion. The set screw can also bend and deform if it is advanced against a helical blade/lag screw that is not fully seated into position, thereby potentially compromising its function.

Conclusion

The TFNa set screw allows for potential fracture during implant insertion leading to uncontrolled collapse, early excessive proximal femoral shortening, and rotational instability of the helical blade/lag screw. Similar failures in the TFNa can be prevented by having the surgeon inspect the proximal screw aperture after attachment of the proximal aiming aim to ensure the set screw has not been deployed prematurely.

Level of evidence

Therapeutic Level III.

Available only for authorised users

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Title: Bent or broken: analysis of set screw fracture in the TFNa implant
Author: Matthew Klima
Publication date: 01-12-2021
Publisher: Springer International Publishing
Published in: Journal of Orthopaedics and Traumatology / Issue 1/2021
Print ISSN: 1590-9921
Electronic ISSN: 1590-9999
DOI: https://doi.org/10.1186/s10195-021-00594-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Bent or broken: analysis of set screw fracture in the TFNa implant

Abstract

Objectives

Materials and methods

Results

Conclusion

Level of evidence

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Objectives

Materials and methods

Results

Conclusion

Level of evidence

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