Arthrex® AR-1934BCFT-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867023932), received between Dec 19, 2016 and Dec 19, 2016 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2016Failure To Adhere Or Bond

  IT WAS REPORTED THAT TWO BIO COMPOSITE S-TAK SUTURE ANCHORS WERE BEING USED IN A ROTATOR CUFF PROCEDURE. DURING THE PROCEDURE, WHEN THE SURGEON WAS TYING THE GRAFT TO THE GLENOID, THE AR-1934BCFT-2 LOT 600115, SUTURE ANCHOR ((B)(4) (B)(6)) PULLED OUT. THE SAME EVENT HAPPENED WITH THE SECOND AR-1934BCFT-2 LOT 1241015, SUTURE ANCHOR ((B)(4) (B)(6)). THE SURGEON REMOVED THE ANCHORS, AND THE GRAFT, AND CUT THE REMAINING SUTURES FROM THE PATIENT AS HE DECIDED THE ROTATOR CUFF WAS IRREPARABLE AT THIS TIME. THE SURGERY WAS NOT COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6184915 ↗
• InjuryDec 19, 2016Device Operates Differently Than Expected; Unintended Movement

  IT WAS REPORTED THAT TWO BIO COMPOSITE S-TAK SUTURE ANCHORS WERE BEING USED IN A ROTATOR CUFF PROCEDURE. DURING THE PROCEDURE, WHEN THE SURGEON WAS TYING THE GRAFT TO THE GLENOID, THE AR-1934BCFT-2 LOT 600115, SUTURE ANCHOR ((B)(4) (B)(6)) PULLED OUT. THE SAME EVENT HAPPENED WITH THE SECOND AR-1934BCFT-2 LOT 1241015, SUTURE ANCHOR ((B)(4) (B)(6)). THE SURGEON REMOVED THE ANCHORS, AND THE GRAFT, AND CUT THE REMAINING SUTURES FROM THE PATIENT AS HE DECIDED THE ROTATOR CUFF WAS IRREPARABLE AT THIS TIME. THE SURGERY WAS NOT COMPLETED.

  Patient problems: Failure to Anastomose

  MAUDE report 6184912 ↗