[Reportable incidents with surgical instruments in orthopedic surgery]

Area of Science:

• Orthopedic Surgery
• Medical Device Safety
• Surgical Instrument Failure

Context:

• Orthopedic surgical instruments, classified as low-risk devices, have unlimited reusable applications.
• Instrument breakage during surgery, though rare, carries significant risks for patients and surgeons.
• Current regulations may not adequately address the risks associated with reusable orthopedic instruments.

Purpose:

• To evaluate the extent to which instrument failure constitutes a reportable incident in orthopedic surgery.
• To determine the appropriate procedures for managing incidents of surgical instrument failure.
• To analyze the clinical and regulatory implications of instrument breakage in orthopedic procedures.

Summary:

• Breakage of surgical rasps during total hip and knee replacements significantly prolongs operation times, requires larger surgical exposures, and complicates fragment retrieval.
• In severe cases, bone fenestration was necessary for fragment removal, and revision implants were used to address surgical site defects.
• Consequences of instrument failure, including prolonged surgery and need for revision implants, are deemed reportable incidents.

Impact:

• Highlights the need for improved reporting and risk assessment of surgical instrument failures.
• Emphasizes the importance of thorough documentation and communication with manufacturers and regulatory bodies.
• Informs potential revisions to medical device regulations concerning reusable orthopedic instruments.