BIOKNOTLESS ETHIBOND 212738Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705002238), received between Apr 23, 2019 and Apr 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2019Migration; Migration

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN ARCR SURGERY THE BIOKNOTLESS ETHIBOND ANCHOR CAME OFF FROM THE BONE HOLE WHEN THE SURGEON IMPLANTED INTO THE PATIENT'S SHOULDER. THUS, THE SURGEON COULD NOT IMPLANT AND FIX THE ANCHOR. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM, ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. THERE WERE NO BROKEN PARTS IN THE PATIENT¿S BODY. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO INFORMATION OF SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. THIS REPORT IS FOR A BIOKNOTLESS ETHIBOND ANCHOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8540443 ↗