HEALIX ADVANCE 222426Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705030620), received between Jan 4, 2024 and Jun 8, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Mechanical Jam

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, WHILE USING 2X HEALIX ADVANCE DEVICES, WHEN THE SURGEON TRIED TO REMOVE THE DILATOR FIXATION SUTURE FROM THE STUMP OF THE IMPLANT SHAFT AFTER PLACING THE ANCHOR, IT WAS FOUND THAT THE SUTURE WAS STUCK INSIDE THE STUMP AND COULD NOT BE REMOVED WITHOUT USING A KOCHER TOOL. THE SUTURE WAS REMOVED WITH A KOCHER TOOL AND RELEASED FROM THE SHAFT BEFORE USE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430011 ↗
• MalfunctionJun 8, 2026Mechanical Jam

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, WHILE USING 2X HEALIX ADVANCE DEVICES, WHEN THE SURGEON TRIED TO REMOVE THE DILATOR FIXATION SUTURE FROM THE STUMP OF THE IMPLANT SHAFT AFTER PLACING THE ANCHOR, IT WAS FOUND THAT THE SUTURE WAS STUCK INSIDE THE STUMP AND COULD NOT BE REMOVED WITHOUT USING A KOCHER TOOL. THE SUTURE WAS REMOVED WITH A KOCHER TOOL AND RELEASED FROM THE SHAFT BEFORE USE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428056 ↗
• MalfunctionMay 28, 2026Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE BONE FRACTURED DURING INSERTION OF A 6.5MM HEALX ADV SP BIOC ANCHOR DUE TO VERY SOFT BONE. ANOTHER ANCHOR FROM A DIFFERENT WAS USED AND FUNCTIONED NORMALLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. THE SURGEON CONFIRMED THAT NO RESIDUE REMAINED IN THE BODY AND THERE WAS NO IMPACT ON THE PATIENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25318252 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE HEALIX ADVANCE ANCHOR BROKE DURING INSERTION. AFTER THE BREAKAGE, IT WAS COMPLETELY REMOVED, AND NO REMNANTS REMAINED IN THE BODY. THEN, FASTIN WAS USED, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219316 ↗
• MalfunctionJan 31, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE ANCHOR ON THE 6.5MM HEALX ADV SP BIOC ANCHOR DEVICE BROKE WHILE THREADING THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18617334 ↗
• MalfunctionJan 4, 2024Crack; Crack

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN UNKNOWN SURGICAL PROCEDURE THE 6.5MM HEALX ADV SP BIOC ANCHOR DEVICE CRACKED DURING INSERTION. THERE WAS A POSSIBILITY THAT OF A BONE QUALITY OR A TECHNICAL ERROR. ANOTHER DEVICE WAS INSERTED INTO A DIFFERENT POSITION TO COMPLETE THE PROCEDURE. THE SURGEON CONFIRMED THAT THERE WERE NO BROKEN PIECES. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18442298 ↗