Arthrex® AR-1934BCF-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867023901), received between Aug 16, 2016 and Aug 21, 2025 — classified as 1 injury, 1 malfunction.

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 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.

• MalfunctionAug 21, 2025Break; Break

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL AN ISSUE INVOLVING AN AR-1934BCF-24 2.4 MM BIOCOMPOSITE SUTURETAK FRACTURE IN HALF. DURING THE PROCEDURE, A 2.4 MM SUTURETAK ANCHOR WAS REQUESTED AND PLACED USING STANDARD SURGICAL TECHNIQUE, WHICH INCLUDED DRILLING WITH A 2.4 MM BIT AND IMPLANT IMPACTION. UPON INSERTION, THE IMPLANT FRACTURED IN HALF AT THE ANCHOR. IT WAS NOTED THAT A PREVIOUS IMPLANT OF THE SAME TYPE HAD BEEN PLACED WITHOUT ISSUE. PRIOR TO PLACEMENT, THE IMPLANT STEM APPEARED SOMEWHAT UNSTABLE; HOWEVER, INSERTION WAS STILL ATTEMPTED FOLLOWING ALL RECOMMENDED STEPS. A THIRD IMPLANT WAS SUBSEQUENTLY PLACED AND FUNCTIONED CORRECTLY. THE INCIDENT OCCURRED ON 7/14/2025 DURING A COLLATERAL LIGAMENT RECONSTRUCTION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 08/13/2025: ALL FRAGMENTS OF THE AR-1934BCF-24 2.4 MM BIOCOMPOSITE SUTURETAK WERE RETRIEVED. THE CASE WAS COMPLETED USING A REPLACEMENT AR-1934BCF-24 FROM LOT NUMBER 15044246. NO PROCEDURAL DELAYS WERE REPORTED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22866245 ↗
• InjuryAug 16, 2016Break; Detachment Of Device Component; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ORIF RIGHT ELBOW CORONOID FRACTURE REPAIR, THE BIO-COMPOSITE SUTURETAK SUTURE ANCHOR BROKE ON INSERTION. THE SURGEON ATTEMPTED MULTIPLE TIMES TO REMOVE THE ANCHOR BUT WAS NOT ABLE TO DO SO. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5878365 ↗