Adverse Events Associated With Ultrasonic Bone Saws.

Area of Science:

• Medical device safety and performance analysis.
• Surgical technology and risk assessment.

Background:

• Ultrasonic bone saws are gaining traction, replacing traditional osteotomy tools in craniofacial and rhinoplasty procedures.
• Understanding potential adverse events is crucial for enhancing surgical safety.

Purpose of the Study:

• To classify and analyze device- and patient-related events linked to ultrasonic bone saw usage.
• To identify common malfunctions and patient injuries associated with these devices.

Main Methods:

• Analysis of 432 medical device reports from the FDA's MAUDE database (2014-2024) concerning Piezosurgery and Sonopet devices.
• Inclusion of search terms: "piezo saw," "piezoelectric," "piezosurgery," and "sonopet."

Main Results:

• Most common device issues included inability to irrigate (186 reports), device overheating/melting (148), and insert tip fracture (58).
• Patient-related events occurred in 31 cases, leading to 15 morbidities, primarily thermal burns (13) and iatrogenic foreign bodies (8).
• Device malfunctions caused 18 significant case delays and 1 abortion, with patient injuries requiring conservative treatment (10 cases) or further surgery (7 cases).

Conclusions:

• Device overheating, fracture, thermal burns, and foreign bodies are key risks associated with ultrasonic bone saws.
• Awareness of these risks can guide surgeons in improving the safe application of ultrasonic bone saws in craniofacial and rhinoplasty surgeries.