Journal of Failure Analysis and Prevention

, Volume 16, Issue 5, pp 849–857 | Cite as

Failure Analysis of Internal Fixation Medical Devices: Overview and Case Studies

  • Ryan P. Birringer
  • Gabriel S. Ganot
  • Brad A. James
Technical Article---Peer-Reviewed
  • 209 Downloads

Abstract

Internal fixation devices, and specifically bone plate and screw assemblies, are among the most common implantable medical devices that a failure analyst may encounter. These devices most often fracture by fatigue crack initiation and growth. This article discusses potential root causes of internal fixation device fractures and describes the process of metallurgical and nondestructive examination of these assemblies. Two fractured internal fixation device case studies are reviewed.

Keywords

Medical devices Failure analysis Fatigue Internal fixation Bone plate 

References

  1. 1.
    O. Pohler, in Failures of Orthopedic Implants, ASM Handbook, Failure Analysis and Prevention, vol. 11, 9th edn, ed. by W. T. Becker, R.J. Shipley (ASM International, Metals Park, 1986), pp. 670–694Google Scholar
  2. 2.
    B. A. James, in Medical Device Failure Analysis, ASM Handbook, Materials for Medical Devices, vol. 23, 1st edn. ed by R. Narayan (ASM International, Metals Park, 2012), p. 343–359Google Scholar
  3. 3.
    Standard Specification and Test Method for Metallic Bone Plates. ASTM F 382-14, ASTM Volume 13.01 Medical and Surgical Materials and Devices (I)Google Scholar
  4. 4.
    S. Koh, R.P. Morris, R.M. Patterson, J.P. Kearney, W.L. Buford Jr., S.F. Viegas, Volar fixation for dorsally angulated extra-articular fractures of the distal radius: a biomechanical study. J. Hand Surg. Am. 31(5), 771–779 (2006)CrossRefGoogle Scholar
  5. 5.
    M.L. Villarraga, in Clinical Performance of Rods, Plates, Screws and Cages, Spine Technology Handbook, 1st edn. ed by S.M. Kurtz, A.A. Edidin (Elsevier, New York, 2006), pp. 209–240Google Scholar
  6. 6.
    L.D. Zardiackas, L.D. Dillon, in Failure Analysis of Metallic Orthopedic Devices, Encyclopedic Handbook of Biomaterials and Bioengineering Part B: Applications, vol. 1, 1st edn. ed by D.L. Wise, D.J. Trantolo, D.E. Altobelli, M.J. Yaszernski, J.D. Gresser, E.R. Schwartz (CRC Press, New York, 1995), pp. 123–170Google Scholar
  7. 7.
    H.K. Uhthoff, P. Poitras, D.S. Backman, Internal plate fixation of fractures: short history and recent developments. J. Orthop. Sci. 11(2), 118–126 (2006)CrossRefGoogle Scholar
  8. 8.
    S. Lovald, S. Kurtz, Applications of polyetheretherketone in trauma, arthroscopy, and cranial defect repair, in PEEK Biomaterials Handbook, 1st edn., ed. by S. Kurtz (Elsevier, New York, 2012), pp. 243–260CrossRefGoogle Scholar
  9. 9.
    S.M. Perren, Evolution of the internal fixation of long bone fractures. The scientific basis of biological internal fixation: choosing a new balance between stability and biology. J. Bone Joint Surg. Br. 84(8), 1093–1110 (2002)CrossRefGoogle Scholar
  10. 10.

Copyright information

© ASM International 2016

Authors and Affiliations

  • Ryan P. Birringer
    • 1
  • Gabriel S. Ganot
    • 1
  • Brad A. James
    • 1
  1. 1.Materials and Corrosion Engineering PracticeExponent, Inc.Menlo ParkUSA

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