Adverse Events Associated With Ultrasonic Bone Saws.

Abstract

To classify device- and patient-related events associated with the use of ultrasonic bone saws. The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried for medical device reports from January 2014 through June 2024. The search included the following terms: "piezo saw," "piezoelectric," "piezosurgery," and "sonopet." Medical device reports for Piezosurgery (Mectron, Carasco, Italy) and Sonopet Ultrasonic Bone Aspirator (Stryker, Kalamazoo, MI) were analyzed and data extracted. In total, 673 reports were reviewed and 432 were included for analysis, 64 and 368 of which involved Piezosurgery and Sonopet, respectively. The most common device-related events were inability to irrigate (n = 186), overheating or melting of the device (n = 148), and fracture of the insert tip (n = 58). Due to malfunctions, 18 clinically significant case delays and 1 case abortion were reported. Patient-related events occurred in 31 cases, resulting in 15 morbidities. The most common patient injury was thermal burn (n = 13) followed by iatrogenic foreign body (n = 8). Patient-related events resulted in conservative treatment in 10 cases and further surgical intervention in 7 cases. Ultrasonic bone saws are used increasingly in place of oscillating saws and conventional osteotomies for craniomaxillofacial and rhinoplasty surgery. Understanding the risks of device overheating or fracture, and the associated risk of thermal burn or iatrogenic foreign body may help surgeons improve the safe use of these devices.