Arthrex® AR-2323BCT-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867251069), received between Apr 22, 2020 and Oct 27, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Break; Break

  ADDITIONAL INFORMATION: AN AR 2323BCT-2 WAS USED TO COMPLETE THE CASE. THE SURGERY EXPERIENCED A MINOR DELAY OF APPROXIMATELY 5 MINUTES. HOWEVER, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT DUE TO THIS DELAY. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED DURING OR FOLLOWING THE PROCEDURE IN RELATION TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390110 ↗
• MalfunctionFeb 19, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2323BCT-2 BIOCOMPOSITE SWIVELOCK C WAS ANCHORED BUT HAD AN ISSUE WITH BEING UNABLE TO REMOVE THE INSERTER AND THE KNOB FROM THE SUTURES AT THE END. THEY WERE ABLE TO CUT THE SUTURES, AND THE REP CHECKED THE INSERTER AFTER THE CASE AND WAS ABLE TO REMOVE THE SUTURES WITH HEMOSTATS. THE REP SAID THE SUTURES WERE INTACT WITHOUT ANY KNOTS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 02/07/2025: THIS OCCURRED IN A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. THERE WAS NO CASE DELAY AND NO ADDED ANESTHESIA ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412034 ↗
• MalfunctionMay 13, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, WHEN THE SURGEON IMPLANTED THE ANCHOR, AND THE REPAIR WAS NEAR COMPLETION, THE SURGEON THEN USED THE EYELET FIBERWIRE FROM THE AR-2323BCT-2, (LOT:11938015), AND AS THE SURGEON PULLED ON THE FIBERWIRE, THE FIBERWIRE SNAPPED IN HALF AND THE ANCHOR PULLED OUT. THIS LED TO A COMPLETE FAILURE OF THE REPAIR AND THE SURGEON HAS TO ESSENTIALLY START OVER.

  Patient problems: Insufficient Information

  MAUDE report 19306095 ↗
• MalfunctionApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 12/22/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-2323BCT-2 SWIVELOCK FAILED WHEN SURGEON REMOVED INSERTER HANDLE AND ALL THE SUTURES CAME OUT OF THE PEEK ANCHOR. THIS WAS DISCOVERED DURING A PROCEDURE ON THE (B)(6) 2021. AFTER ADDITIONAL INFORMATION RECEIVED ON 12/22/2021, FACILITY REPRESENTATIVE HAS CONFIRMED THAT THIS OCCURRED DURING A RCR AND ALL THE SUTURES THAT CAME OFF THE ANCHOR AND THE IMPLANTED ANCHOR, WERE REMOVED FROM INSIDE THE PATIENT. SURGEON USED THE SAME BONE SOCKET PREVIOUSLY CREATED TO INSERT A NEW SWIVELOCK ANCHOR FROM THE SAME LOT NUMBER AS THE FAILED ONE. CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 19203520 ↗
• MalfunctionApr 22, 2024Defective Device; Defective Device

  ON 7/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2323BCT-2 SWIVELOCK HANDLE WAS SLIPPING INTO THE DEVICE SHAFT AS THE SURGEON WAS ATTEMPTING TO MANUALLY SCREW IN THE ANCHOR. BECAUSE OF THIS, THE ANCHOR COULD NOT BE IMPLANTED. CASE WAS COMPLETED WITH ANOTHER AR-2323BCT-2 SWIVELOCK AND NO FURTHER ISSUES HAS BEEN REPORTED. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 19154033 ↗
• MalfunctionJun 9, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2323BCT-2 BIOCOMPOSITE SWIVELOCK ANCHOR BROKE DURING INSERTION. ALL THE BROKEN FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED USING ANOTHER AR-2323BCT-2 BIOCOMPOSITE SWIVELOCK. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 5/17/2023: THIS WAS DISCOVERED DURING AN RCR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097446 ↗
• MalfunctionOct 26, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT WHILE THE SURGEON WAS TAPPING THE AR-2323BCT-2 ANCHOR DOWN TO BONE THE EYELET SUTURE BROKE OFF THE EYELET AND THE EYELET CAME FREE. THE SURGEON REMOVED THE EYELET WITH A GRASPER. THIS WAS DISCOVERED DURING USE IN A PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING A AR-2323BCC. NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 12696544 ↗
• MalfunctionJul 6, 2021Break; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED DURING A ROTATOR CUFF REPAIR PROCEDURE, AFTER INSERTING THE AR-2323BCT-2 SWIVELOCK. ADDITIONAL INFORMATION 6/15/2021. IT WAS REPORTED DURING A ROTATOR CUFF REPAIR PROCEDURE, THE SURGEON STARTED TO INSERT THE AR-2323BCT-2 SWIVELOCK MEDIALLY. HALFWAY THROUGH INSERTION, THE SURGEON DECIDED HE NEEDED TO TAKE IT OUT AND RECHECK THE ANGLE. AS HE WAS PULLING THE STILL INTACT ANCHOR OUT, THE EYELET TORE AWAY FROM THE DRIVER AND EYELET SUTURES AND WAS LEFT IN THE BONE. ADDITIONAL INFORMATION 6/17/2021. IT WAS REPORTED DURING A ROTATOR CUFF REPAIR PROCEDURE, THE SURGEON STARTED TO INSERT THE AR-2323BCT-2 SWIVELOCK MEDIALLY. HALFWAY THROUGH INSERTION, THE SURGEON DECIDED HE NEEDED TO TAKE IT OUT AND RECHECK THE ANGLE. AS THE SURGEON REMOVED THE DEVICE THE AR0-2323BCT-2 BROKE. THE REMAINING PARTS OF THE ANCHOR AND DRIVER WERE REMOVED WHEN HE PULLED IT OUT AND THE BROKEN EYELET REMAINS IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 12124240 ↗
• MalfunctionJun 14, 2021Material Split, Cut or Torn

  IT WAS REPORTED AFTER PUTTING IN THE AR-2323BCT-2 SWIVELOCK LATERALLY, THE SUTURES TORE WHEN THE SURGEON PULLED THE TAB OFF. THE REP STATED ALL BROKEN SUTURE FRAGMENTS WERE FULLY RETRIEVED, AND THE ANCHOR BODY REMAINED WHOLE AND SECURE WITHIN THE INTENDED IMPLANTATION SITE. THE SUTURES TORE AFTER THE LATERAL ROW ANCHOR WAS IMPLANTED AND DID NOT AFFECT THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11990896 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SHOULDER REPAIR SURGERY ON (B)(6) 2020 IN WHICH AR-2324BCT-2 & AR-2323BCT-2 WERE IMPLANTED. THE PATIENT HAS BEEN EXPERIENCING POST-OP SYMPTOMS OF REDNESS, SWELLING AND DRAINING. THE PATIENT HAS BEEN REFERRED TO AN IMMUNOLOGIST. THE IMMUNOLOGIST IS REQUESTING SAMPLE PRODUCT OF AR-2324BCT-2 & AR-2323BCT-2. THE IMMUNOLOGY APPOINTMENT IS SCHEDULED FOR (B)(6) 2020. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 4/01/2020: THE ORIGINAL PROCEDURE PERFORMED WAS A LEFT ROTATOR CUFF REPAIR (TWO ANCHORS SUTURE BRIDGE) SUBACROMIAL DECOMPRESSION AND SUB PECTORALIS BICEPS TENODESIS. THE FACILITY REPORTED AR-2324BCT-2 (LOT: 10431237) & AR-2323BCT-2 (LOT: 10268328) WERE THE ONLY ARTRHEX PRODUCTS IMPLANTED DURING THE PROCEDURE. THE PATIENT'S SYMPTOMS FIRST STARTED ON (B)(6) 2020. POSTOPERATIVELY, THE PATIENT DEVELOPED CELLULITIS OVERLYING THEIR LEFT SHOULDER AND UPPER ARM. THE PATIENT WAS INITIALLY PLACED ON KEFLEX WHICH DID NOT SEEM TO IMPROVE THEIR SYMPTOMS AND WAS THEN TRANSITIONED TO CLINDAMYCIN AGAIN WITH NO SIGNIFICANT CHANGES. THE PATIENT WAS THEN REFERRED TO INFECTIOUS DISEASE WHO STARTED THEM ON IV VANCOMYCIN. AGAIN

  Patient problems: Cellulitis; Edema; Erythema; Swelling

  MAUDE report 9985414 ↗