Management and decision-making after implantation of a non-sterilized implant in a trauma patient.

BACKGROUND/PURPOSE: Sterility errors in orthopaedic surgery are under-recognized and lack specific management guidelines. We describe a case of inadvertent implantation of a non-sterilized distal radius plate and propose a structured, mechanism-based framework for risk assessment and decision-making in such scenarios.

METHODS

A root cause analysis (RCA) was conducted to identify contributing factors at organizational, human, and system levels. The patient's treatment involved leaving the implant in place while administering antibiotics (amoxicillin/clavulanic acid for 7 days), with a 4-year follow-up showing no infection.

RESULTS

The RCA revealed multiple breaches in safety barriers, including unauthorized access to the sterilization area, unchecked chemical indicators and insufficient staff supervision. Despite the sterility breach, no infection occurred, highlighting the role of rapid management and structured surveillance.

CONCLUSION

This case underscores the need for standardized protocols to manage sterility breaches, including mandatory sterility verification and integration into surgical checklists. Our mechanism-based framework provides a practical tool for clinicians facing similar incidents, but further validation through multi-centre studies is warranted.