Arthrex® AR-1322BCSTRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867392069), received between Aug 30, 2023 and May 29, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Break; Break

  ON 05/05/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT (QTY. 2) OF AN AR-1322BCST 2.4 SINGLE LOADED SUTURETAPE HAD SLIDING COVERS TO THE SUTURES THAT WOULD NOT OPEN. A FREER WAS REQUIRED TO PRY THEM OPEN. BOTH FUNCTIONED PROPERLY ONCE OPENED ON THE BACK TABLE, SLIDING OPEN AND CLOSED AS EXPECTED. ADDITIONALLY, ONE OF THE NEEDLES ON ONE OF THE ANCHORS BROKE DURING THE PROCEDURE. ALL NEEDLE FRAGMENTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT, WITH CONFIRMATION VIA X-RAY. A FREE NEEDLE WAS USED TO COMPLETE THE REPAIR, AND THE ANCHOR REMAINED IN PLACE AND WAS USED FOR THE REPAIR. THERE WAS NO CASE DELAY, AND NO HARM WAS REPORTED TO THE PATIENT. THIS WAS DISCOVERED DURING A LATERAL ANKLE STABILITY WITH BROSTRUM REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22109606 ↗
• MalfunctionMay 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 04/26/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1322BCST 2.4 SINGLE LOADED SUTURETAPE PULLED OUT DURING A LATERAL ANKLE PROCEDURE ON (B)(6) 2025. NO PART OF THE IMPLANT STAYED IN THE PATIENT, AND A BACKUP WAS AVAILABLE TO COMPLETE THE CASE WITHOUT A DELAY. THIS OCCURRED DURING USE, WITH NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054994 ↗
• MalfunctionMar 28, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 3/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-1322BCST SINGLE LOADED SUTURETAPE S-TAK ASSY FAILED. THE FIRST SUTURETAK KNOTTED AT THE NITINOL LOOP AND BROKE OFF IN THE PATIENT'S TISSUE. THE SECOND SUTURETAK ALSO KNOTTED, AND THE NITINOL WIRE POPPED OFF ENTIRELY. THE SURGEON WAS ABLE TO REMOVE ALL THE BROKEN FRAGMENTS. THIS WAS DISCOVERED DURING A BROSTROM REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED ABOUT TEN MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 18992388 ↗
• MalfunctionMar 28, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-1322BCST SINGLE LOADED SUTURETAPE S-TAK ASSY FAILED. THE FIRST SUTURETAK KNOTTED AT THE NITINOL LOOP AND BROKE OFF IN THE PATIENT'S TISSUE. THE SECOND SUTURETAK ALSO KNOTTED, AND THE NITINOL WIRE POPPED OFF ENTIRELY. THE SURGEON WAS ABLE TO REMOVE ALL THE BROKEN FRAGMENTS. THIS WAS DISCOVERED DURING A BROSTROM REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED ABOUT TEN MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 18992365 ↗
• MalfunctionFeb 23, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-1322BCST 2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY ANCHOR BROKE OFF AT THE TIP DURING INSERTION WHEN DRILLING INTO HARD BONE. THE CASE WAS COMPLETED BY PUTTING IN 3.0 ANCHORS FOR DRILLING INSTEAD WITH NO ISSUES. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18769253 ↗
• MalfunctionFeb 23, 2024Break; Break

  ON 02/02/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-1322BCST 2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY ANCHOR BROKE OFF AT THE TIP DURING INSERTION WHEN DRILLING INTO HARD BONE. THE CASE WAS COMPLETED BY PUTTING IN 3.0 ANCHORS FOR DRILLING INSTEAD WITH NO ISSUES. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18769221 ↗
• MalfunctionJan 15, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 12/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1322BCST SUTURETAPE BENT AND BROKE. THIS WAS DISCOVERED DURING A TRICEPS REPAIR PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING ANOTHER ANCHOR. ADDITIONAL INFORMATION REQUESTED..

  Patient problems: Insufficient Information

  MAUDE report 18511581 ↗
• MalfunctionJan 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 12/12/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1322BCST 2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY NITINOL EYELET POPPED OFF THE NEEDLE AND THE SUTURE WAS NO LONGER ATTACHED TO THE NEEDLE. THE EYELET WAS REMOVED FROM THE PATIENT WITH NO FRAGMENTS LEFT INSIDE THE PATIENT. THE CASE WAS COMPLETED BY OPENING ANOTHER AR-1322BCST (UNKNOWN LOT) AND USING A FREE NEEDLE INSTEAD OF THE NITINOL EYELET LOOP. THERE WAS A 5-10 MINUTE DELAY IN THE PROCEDURE. THIS WAS DISCOVERED DURING A CMC ARTHROPLASTY PROCEDURE ON (B)(4) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18466428 ↗
• MalfunctionAug 30, 2023Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated

  ON 08/01/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1322BCST SINGLE LOADED SUTURE TAPE ANCHOR PULLED OUT. THIS OCCURRED DURING A PROCEDURE, THEY HAD TO SWITCH TO A LARGER ANCHOR TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17653318 ↗