FASTIN ETHIBOND 222722Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705008247), received between Jan 22, 2020 and Nov 29, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A LEFT CALCANEAL OSTEOTOMY AND FIXATION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 4.9 HEALIX ADV SP PEEK CE DEVICE WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER ONE TO CONTINUE WITH THE SURGERY, WHEN TIGHTENED THE FASTIN RC ANCHOR WITH ETHIBOND W/NEEDLES BROKE OFF. 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 18230291 ↗
• MalfunctionOct 6, 2020Break; Break

  IT WAS REPORTED THAT DURING THE UNKNOWN SURGERY, WHEN REMOVED THE SHAFT, NOTED THE ANCHOR WAS BROKEN AND THE SUTURE WAS BROKEN AS THE PHOTO SHOWS. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10638588 ↗
• MalfunctionJan 22, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA PHONE THAT DURING A ROTATOR CUFF REPAIR WHEN SCREWING THE ANCHOR THE FASTIN RC 5.0 ETHIBOND W/NDLS WAS BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9618456 ↗