SONICFUSION 1910-1001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327096019), received between Mar 8, 2019 and Dec 2, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2019Failure to Power Up; Failure to Power Up

  AS REPORTED: "OPENED SET, AND WIRES WERE BURNT. HANDPIECE WAS NON-OPERABLE. PATIENT OUTCOME WAS NOT AFFECTED!"

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9394939 ↗
• MalfunctionMar 8, 2019Electrical /Electronic Property Problem; Defective Device; Material Deformation; Electrical /Electronic Property Problem; Material Deformation

  PRIMARY PROCEDURE, LEFT ANKLE ARTHROSCOPY AND LATERAL STABILIZATION REPAIR. IT WAS REPORTED THAT THE WAND WAS NOT FUNCTIONING PROPERLY. THE WAND WAS TESTED ON TWO SONIC GENERATORS WITH THE SAME RESULT. SURGERY WAS COMPLETED USING COMPETITOR ANCHORS WITH NO DELAY AS DISCOVERY WAS MADE WHILE A DIFFERENT PART OF THE PROCEDURE WAS BEING COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405182 ↗