FASTIN ETHIBOND 222723Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705008254), received between Jun 19, 2019 and Sep 28, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923305 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR RECONSTRUCTION OF A PATELLAR LIGAMENT IN THE KNEE IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE ANCHOR WAS BROKEN OFF AND THE SUTURE WAS BROKEN. ALL BROKEN PARTS WERE REMOVED. THE USER CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY WHEN IMPLANTED IN PATIENT, THE SUTURE WAS BROKEN OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395798 ↗
• MalfunctionMay 3, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024, THE FASTIN 5.0 FASTIN ANCHOR ETHIBOND WITHOUT NEEDLES DEVICE SUTURE WAS BROKEN OFF WHEN TIGHTENED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 19236615 ↗
• MalfunctionJun 19, 2019Failure to Advance; Failure to Advance

  IT WAS REPORTED BY THE AFFILIATE THAT DURING THE SURGICAL TREATMENT OF AN ANKLE INSTABILITY, THE FASTIN 5.0 FASTIN ANCHOR WITH GREEN AND WHITE ETHIBOND WITHOUT NEEDLES CANNOT BE FIXED. THIS ANCHOR WAS REMOVED AND A NEW ONE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGERY TIME WAS NOT DELAYED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8714586 ↗