SONICFUSION 1910-2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613252495079), received between Mar 11, 2019 and Oct 27, 2023 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2023Failure to Power Up; Failure to Power Up

  AS REPORTED: "PLUGGED IN POWER CORD FOR SONIC ANCHOR GENERATOR AND IT NEVER POWERED UP. TRIED SECOND POWER GENERATOR CORD AND STILL DID NOT TURN ON".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026185 ↗
• MalfunctionSep 28, 2023Failure to Power Up; Failure to Power Up

  AS REPORTED: "IT WOULD NOT PASS THE STARTING TEST."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839799 ↗
• MalfunctionSep 7, 2023Failure to Power Up; Failure to Power Up

  AS REPORTED: "MALFUNCTION WITH SONIC ANCHOR CONSULT. LOCKDOWN ERROR L01000".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17697197 ↗
• MalfunctionSep 4, 2023Use of Device Problem; Use of Device Problem

  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 17676613 ↗
• MalfunctionJan 27, 2023Failure to Power Up; Failure to Power Up

  AS REPORTED: "MY TEAM DID NOT HAVE A REP AVAILABLE TO COVER THIS CASE. AS I WAS IN A SEPARATE CASE, I STEPPED OUT FOR A PHONE CALL FROM MY COLLEAGUE WHO STATED THAT THE FACILITY NEEDED TO TROUBLESHOOT AND SHE WASN'T AWARE. I GAVE THEM A CALL AND WALKED THEM THROUGH THE STRYKER SONIC ANCHOR TROUBLE SHOOTING PER THE TECHNIQUE GUIDE. AS NOBODY WAS PHYSICALLY THERE, I DO NOT KNOW IF MY TROUBLESHOOT ACTIONS WERE TAKING. THE FACILITY STATES THAT THEY DID ALL OF THE ACTIONS (UNPLUGGING MACHINE, TAKING OFF THE TIP OF THE HANDPIECE AND RE ATTACHING, RESTARTING, RUNNING A TEST PRIOR). THEY CLAIM THAT THEY GENERATOR WAS FAULTY AND IT WAS NOT ALLOWING THEM TO RUN THE "TEST RUN". I WAS THEN HUNG UP ON BY THE FACILITY. I GET A TEXT MESSAGE FROM THE FACILITY MATERIALS MANAGER STATING THAT THE SONIC ANCHOR DID NOT WORK, AND HE SENT ME A PHOTO OF THE BOX. APPARENTLY THEY OPENED AND ANCHOR AND TRIED TO USE IT. I DO NOT KNOW EXACTLY WHAT HAPPENED HERE AS THEY SHOULD NOT HAVE OPENED THE ANCHOR PRIOR TO DOING THE TEST RUN. WHILE I WAS ON SPEAKER PHONE TRYING TO TROUBLE SHOOT, THE DOCTOR SAID "THIS PATIENT HAS BEEN UNDER FOR 3 HOURS, THIS ANCHOR DOESN'T WORK. THERE IS NOBODY HERE" AND PROCEEDING TO HANG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16254617 ↗
• MalfunctionDec 3, 2021Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THE FOLLOWING: "ON (B)(6), 2021, THE SONIC ANCHOR IMPLANT WAS NOT 'MELTING' CORRECTLY AND WAS PULLED OUT OF THE PATIENT'S FOOT. THROUGH TRIAL AND ERROR, SEVERAL MORE IMPLANTS ALSO FAILED TO 'MELT' CORRECTLY. DRILLED AND THEN TRY TO IMPLANT BIOABSORBABLE PIECE. SONIC ANCHOR IS ONLY MELTING TOP PORTION OF IMPLANT. TROUBLESHOOTED THE MACHINE TODAY AND IT DID NOT WORK. SURGERY WAS COMPLETED WITH A SONIC ANCHOR FROM ANOTHER COMPANY. REPORTER WILL PROVIDE THE PRODUCT CATALOG INFORMATION FOR THE MACHINE LATER."

  Patient problems: Failure of Implant

  MAUDE report 12928514 ↗
• MalfunctionSep 16, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THE SONIC GENERATOR STOPPED TURNING ON, AND COULD NOT BE TURNED ON DURING SURGERY. A COMPETITOR DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481592 ↗
• MalfunctionFeb 25, 2021Image Display Error/Artifact; Image Display Error/Artifact

  AS REPORTED: GENERATOR WAS PLUGGED IN AND TURNED ON. GENERATOR GAVE A LOCKDOWN ERROR "L01000." ADDITIONALLY REPORTED: SURGEON USED A COMPETITIVE PRODUCT FOR FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382439 ↗
• MalfunctionNov 3, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT FOR A PROCEDURE TO PLACE SONIC ANCHORS IN THE PATIENT'S RIGHT FOOT, IT WAS DISCOVERED THAT THE 3-PRONG SOCKET IN THE BACK OF THE GENERATOR WAS SUNKEN IN AND THE UNIT WOULD NOT TURN ON. COMPETITOR ANCHORS WERE USED TO COMPLETE THE CASE SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10781443 ↗
• MalfunctionApr 13, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  AS REPORTED: "THIS WAS OUR SECOND SONIC ANCHOR CASE OF THE DAY. OUR FIRST SONIC ANCHOR CASE WENT PERFECTLY AND THE MACHINE WAS FUNCTIONING FINE. DURING OUR SECOND CASE, THE MACHINE'S TOUCH SCREEN STOPPED WORKING. THE SCREEN WOULD NOT LET ME ADVANCE TO THE TEST SCREEN. BASICALLY WHEN YOU WOULD TOUCH THE SCREEN, NOTHING WOULD HAPPEN. SINCE WE COULD NOT ADVANCE TO THE TEST SCREEN, WE WERE NOT ABLE TO USE THE SONIC ANCHOR IMPLANT." ADDITIONALLY REPORTED: DELAY WAS "10-15 MINUTES TRYING TO TROUBLESHOOT". COMPETITOR DEVICE "MITEK SUTURE ANCHOR" WAS IMPLANTED INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9954496 ↗
• MalfunctionJan 9, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A PRIMARY FOOT PROCEDURE, THE SONIC GENERATOR WAS POWERED UP. THE TOUCH SCREEN WOULD NOT REGISTER ANY TOUCHES, AND A LOUD, HIGH-PITCHED NOISE CAME FROM WITHIN THE GENERATOR. THE SCREEN THEN GENERATED AN ERROR MESSAGE: "F00400 SYSTEM FAULT". THE DEVICE WAS PLUGGED INTO OTHER OUTLETS AND EXHIBITED THE SAME BEHAVIOR. SURGERY WAS COMPLETED SUCCESSFULLY WITH AN OVERALL DELAY OF APPROXIMATELY 25 MINUTES. THE REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9569766 ↗
• MalfunctionJul 8, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem; Device Displays Incorrect Message

  AS REPORTED: "AN ERROR MESSAGE OCCURRED. THE MACHINE WILL NOT GO PAST THE ERROR SCREEN". REPORTER INDICATED THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT/ USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8767255 ↗
• MalfunctionMay 10, 2019Device Displays Incorrect Message

  WHEN RUNNING THE TEST ON THE GENERATOR IT WOULD FLASH 100% AND THE "X" AT THE SAME TIME, THEN REQUIRE A TEST AGAIN. COULD NOT GET PAST THE TEST SCREEN TO USE FOR PROCEDURE. EVENT OCCURRED IN OPERATING ROOM WHILE PATIENT WAS UNDER ANESTHESIA FOR A KIDNER PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8601757 ↗
• MalfunctionMar 11, 2019Smoking

  MACHINE STARTED SMOKING INSIDE OPERATING ROOM AND CLEANING CREW NOTICED. THIS HAPPENED AFTER HOURS AND DID NOT OCCUR DURING A CASE.

  Patient problems: No Patient Involvement

  MAUDE report 8409372 ↗