Objectives: To compare reports of implant fatigue failure submitted to the FDA of 2 commonly used cephalomedullary nails. Methods: In total, 2724 medical device reports from the FDA's MAUDE database from Jan 2015 to Oct 2019 were reviewed for the Trochanteric Femoral Nail–Advanced (TFNa) and Gamma 3 implants. Results: Data from 342 implant failures included in the MAUDE database were analyzed. TFNa and Gamma 3 had 183 and 159 reported fatigue failures, respectively. All failed implants fractured in the same location through the proximal screw aperture. Time from implantation to failure was on average 2 months shorter for TFNa implants that were reported fractured than for Gamma 3 implants reported, a difference that was statistically significant (P < 0.05). In total, 100 implants were reported to have failed within the first 4 months (53 and 47 for TFNa and Gamma 3, respectively). For Gamma 3 implants that failed in the first 4 months, almost all of the available manufacturers' inspection reports revealed implant notches at the point of failure from drilling. For TFNa implants that failed early, only one reported notch was noted in the available inspection reports. Conclusions: In contrast to other studies regarding fatigue failure, reported failures in both TFNa and Gamma 3 occurred earlier than can be attributed to delayed or nonunion. The reported failures of the TFNa in the MAUDE database occurred earlier than did those of the Gamma 3. Early failures of the Gamma 3 seemed to be the result of iatrogenic implant notching. Level of Evidence: Therapeutic Level III. See instructions for authors for a complete description of levels of evidence.
Extracapsular hip fractures occur frequently in the elderly as a result of low-energy trauma. Achieving stable fixation in osteoporotic bone to allow early weight bearing is a key objective in the treatment of these injuries. Many of the intraoperative decisions facing surgeons are directed by first determining fracture stability. Unstable fracture patterns should be fixated with intramedullary nails, aiming to control motion around the implant and at the fracture site. Torsion control devices provide additional stability and control, although their exact indications are not precisely defined. Complications that arise as a result of the early loading can be avoided with a good surgical reduction, meticulous technique, and proper implant selection. Mechanical complications include cutout, inordinate proximal femoral shortening, delayed union, early implant fracture, nail toggle, and cut through/medial migration.
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.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.