SonicAnchor 1910-1271SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327096170), received between Aug 17, 2018 and Dec 3, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2021Activation Failure; Activation Failure

  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 12925482 ↗
• MalfunctionNov 19, 2019Difficult to Insert; Difficult to Insert

  SONIC ANCHOR (2) FAILED TO FIXATE. NEW IMPLANTS WERE USED WITH SUCCESSFUL FIXATION. SLIGHT DELAY IN COMPLETION OF THE PROCEDURE (5 MINUTES) AND EXTRA HOLES WERE DRILLED TO ACCOMMODATE NEW IMPLANTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9345731 ↗
• MalfunctionAug 17, 2018Expiration Date Error

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR TENDON REPAIR, AN EXPIRED DEVICE WAS IMPLANTED IN THE PATIENT. THE ISSUE WAS NOTICED UPON CREATION OF THE BILLING SHEET. SURGEON FEELS THERE IS NO PATIENT HARM AND HAS NO PLANS TO SURGICALLY ADDRESS THE ISSUE. DEVICE WAS NOT HOSPITAL OWNED OR HOSPITAL CONTROLLED. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7792705 ↗