Arthrex® AR-8934BNFRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867050372), received between Aug 25, 2023 and Mar 2, 2026 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Break

  ON 11TH FEB 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-8934BNF, SMALL JOINT BIO-SUTURETAK® WITH NEEDLES, 3.0 MM, WITH 2X #0 FIBERWIRE®, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A MBO PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A REPLACEMENT DEVICE (AR-8934BNF). THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482978 ↗
• MalfunctionApr 2, 2024Break; Break

  ON 03/14/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA E-MAIL THAT AN AR-8934BNF SMALL JOINT BIO-SUTURETAK® WITH NEEDLES FIBER WAS BROKEN. THIS WAS DISCOVERED OUTSIDE THE PATIENT DURING A MENISCUS REPAIR ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19023426 ↗
• MalfunctionJan 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01/02/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8934BNF SUTURE ANCHOR PULLED OUT DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER AR-8934BNF WITH UNKNOWN LOT NUMBERS.

  Patient problems: Insufficient Information

  MAUDE report 18552963 ↗
• MalfunctionNov 14, 2023Break; Break

  ON 10/17/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8934BNF SMALL JOINT BIO-SUTURETAK ANCHOR BROKE. ALL FRAGMENTS WERE REMOVED FROM INSIDE THE PATIENT AND THE CASE WAS COMPLETED USING ANOTHER AR-8934BNF SMALL JOINT BIO-SUTURETAK. THIS WAS DISCOVERED DURING A MODIFIED BROSTROM PROCEDURE ON (B)(6) 2023. THERE WAS NO CASE DELAY AND ADDITIONAL ANESTHESIA WAS NOT ADMINISTERED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129269 ↗
• MalfunctionOct 30, 2023Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT (2) AR-8934BNF SMALL JOINT BIO-SUTURETAK ANCHORS BENT DURING INSERTION. THIS WAS DISCOVERED DURING AN ATFL RECONSTRUCTION PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING ANOTHER DEVICE. SAME DEVICE WITH UNKNOWN LOT NUMBERS WERE USED. NO DELAY NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029799 ↗
• MalfunctionOct 30, 2023Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT (2) AR-8934BNF SMALL JOINT BIO-SUTURETAK ANCHORS BENT DURING INSERTION. THIS WAS DISCOVERED DURING AN ATFL RECONSTRUCTION PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING ANOTHER DEVICE. SAME DEVICE WITH UNKNOWN LOT NUMBERS WERE USED. NO DELAY NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029692 ↗
• MalfunctionAug 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION PROVIDED: IT WAS REPORTED THAT A 10 MIN DELAY OCCURRED WITH NO ADDITIONAL ANESTHESIA. SOME PIECES OF THE IMPLANT WERE BROKEN AND THE SURGEON RETRIEVED IT AND DISCARDED IT. THE CASE WAS COMPLETED WITH AN AR-8934BNF.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17625093 ↗
• MalfunctionAug 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 07/31/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT (QTY.2) AR-8934BNF SMALL JOINT BIO-SUTURETAK ANCHORS PULLED OUT. THIS WAS DISCOVERED DURING AN ATFL PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED BY USING A NEW AR-8934BNF. ADDITIONAL INFORMATION PROVIDED 08/09/2023: IT WAS REPORTED THAT A 10 MIN DELAY OCCURRED WITH NO ADDITIONAL ANESTHESIA. SOME PIECES OF THE IMPLANT WERE BROKEN AND THE SURGEON RETRIEVED IT AND DISCARDED IT. THE CASE WAS COMPLETE WITH AN AR-8934BNF.

  Patient problems: Insufficient Information

  MAUDE report 17625031 ↗