SonicAnchor 1910-1272SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327096163), received between Apr 18, 2018 and Jun 14, 2024 — classified as 2 injuries, 5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Off-Label Use; Off-Label Use

  AS REPORTED: "IT WAS REPORTED THAT AN EXPIRED IMPLANT WAS USED ON THE PATIENT. EXPIRATION DATE WAS 04-MAY-2024. DISCOVERY WAS MADE ON 20/MAY/2024 WHEN ATTEMPTING TO BILL FOR THE IMPLANT. THERE WAS NOT A DELAY TO THE SURGERY. THE SURGEON REQUESTED THE DRILL AND TWO IMPLANTS BE OPENED ONCE HE CONFIRMED A REPAIR WAS NECESSARY. I PULLED THE DRILL AND SONIC ANCHOR IMPLANTS FROM AN IMPLANT KIT. I CONFIRMED THE PRODUCT DESCRIPTIONS ON ALL THREE ITEMS, AND I THOUGHT I CHECKED THE EXPIRATION DATES ON EACH BEFORE HANDING THEM TO HOSPITAL STAFF (NURSE CIRCULATOR) TO INSPECT, OPEN, AND PASS ONTO THE STERILE FIELD. THE ITEM IN QUESTION WAS THE THIRD ITEM OPENED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542027 ↗
• MalfunctionJan 27, 2023Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  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: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16254618 ↗
• 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 12926810 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED: "THE PATIENT SLOWLY DEVELOPED A REACTION AT THE IMPLANT SITE (FIBULA) RESULTING IN PAIN AND SWELLING AFTER AN ATF PRIMARY REPAIR. IMPLANT WAS A BIOABSORBABLE THAT LEFT BEHIND THE PATIENT'S OWN BONE MARROW EDEMA."

  Patient problems: Implant Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 12413622 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED: "THE PATIENT SLOWLY DEVELOPED A REACTION AT THE IMPLANT SITE (FIBULA) RESULTING IN PAIN AND SWELLING AFTER AN ATF PRIMARY REPAIR. IMPLANT WAS A BIOABSORBABLE THAT LEFT BEHIND THE PATIENT'S OWN BONE MARROW EDEMA."

  Patient problems: Implant Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 12413465 ↗
• MalfunctionApr 18, 2018Device Expiration Issue

  AS REPORTED: "PRODUCTS WERE 1 DAY PAST EXPIRATION DAY. DOCTOR WAS NOTIFIED. DOCTOR WILL WRITE DOWN IN NOTES POST OP, AND REVIEW PATIENT ON A REGULAR BASIS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7441504 ↗
• MalfunctionApr 18, 2018Shelf Life Exceeded; Shelf Life Exceeded

  AS REPORTED: "PRODUCTS WERE 1 DAY PAST EXPIRATION DAY. DOCTOR WAS NOTIFIED. DOCTOR WILL WRITE DOWN IN NOTES POST OP, AND REVIEW PATIENT ON A REGULAR BASIS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7441503 ↗