SONICPIN 1910-2602SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327336245), received between Sep 4, 2023 and Sep 4, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionSep 4, 2023Activation Failure; Activation Failure

  AS REPORTED: "SURGEON STATES THAT BOTH 26MM SONIC PINS DID NOT FULLY LIQUIFY WHEN THE ULTRASONIC ENERGY WAS APPLIED. SURGEON STATED THE PINS LIQUEFIED DISTALLY AND PROXIMALLY BUT NOT AT THE CENTER ASPECT. SURGEON STATED THIS HAPPENED TWICE IN A ROW WITH THE 26MM PINS. SURGEON REMOVED THE FIRST 26MM PIN BUT ALLOWED THE 2ND 26MM PIN TO REMAIN IN THE PATIENT AFTER SHE REMOVED SOME OF THE HEAD. THE SURGEON USED A 22MM PIN RIGHT AFTER AND STATED SHE HAD NO ISSUE WITH THE 22MM PIN FULLY LIQUEFYING."

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17676630 ↗
• MalfunctionSep 4, 2023Activation Failure; Activation Failure

  AS REPORTED: "SURGEON STATES THAT BOTH 26MM SONIC PINS DID NOT FULLY LIQUIFY WHEN THE ULTRASONIC ENERGY WAS APPLIED. SURGEON STATED THE PINS LIQUEFIED DISTALLY AND PROXIMALLY BUT NOT AT THE CENTER ASPECT. SURGEON STATED THIS HAPPENED TWICE IN A ROW WITH THE 26MM PINS. SURGEON REMOVED THE FIRST 26MM PIN BUT ALLOWED THE 2ND 26MM PIN TO REMAIN IN THE PATIENT AFTER SHE REMOVED SOME OF THE HEAD. THE SURGEON USED A 22MM PIN RIGHT AFTER AND STATED SHE HAD NO ISSUE WITH THE 22MM PIN FULLY LIQUEFYING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17676609 ↗