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

Abstract

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.