Arthrex® AR-2324BCC-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867097995), received between May 10, 2021 and Sep 2, 2026 — classified as 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568678 ↗
• MalfunctionJun 21, 2024Break; Break

  ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2324BCC-2 BIO COMPOSITE SWIVELOCK BROKE IN HALF DURING INSERTION. BEFORE THE FAULTY ANCHOR, ONE AR-2324BCC-2 BIO COMPOSITE SWIVELOCK WAS SUCCESSFULLY IMPLANTED. THE CASE WAS COMPLETED WITH THE FIRST ANCHOR AND TRYING THE GRAFT ONTO ITSELF. THIS WAS DISCOVERED DURING AN AC JOINT RECONSTRUCTION PROCEDURE ON (B)(6) 2024. THE CASE WAS NOT DELAYED, AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS. ADDITIONAL INFORMATION RECEIVED ON 5/28/2024: ALL THE BROKEN FRAGMENTS WERE SUCCESSFULLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580275 ↗
• InjuryJun 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/18/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1400TB BIO-INTERFERENCE SCREW FULL THREAD, AN AR-1588T ACL TIGHTROPE, (3) AR-2324BCC-2 BIO COMPOSITE SWIVELOCK, (3) AR-4500 MENISCAL CINCH, (4) AR-7200 FIBERWIRE, AND (2) AR-7237 FIBERTAPE WERE ALL IMPLANTED IN THE PATIENT. THIS ACL AND LIGAMENT PROCEDURE TOOK PLACE ON (B)(6) 2023. PATIENT DEVELOPED AN INFECTION POST OPERATIVE AND PATIENT REMAINS ADMITTED TO THE HOSPITAL FOR TREATMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 5/15/2024: THE PATIENT HAS NOT UNDERGONE REVISION SURGERY, AND NO FURTHER INFORMATION HAS BEEN RECEIVED REGARDING THIS INCIDENT.

  Patient problems: Unspecified Infection

  MAUDE report 19530143 ↗
• MalfunctionMay 1, 2024Material Frayed; Material Frayed

  ON 1/14/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2324BCC-2 BIO COMPOSITE SWIVELOCK INTERNAL THREADS OF THE ANCHOR BROKE. SURGEON USED AN AR-7201 TO COMPLETE THE PROCEDURE. THIS WAS DISCOVERED DURING A RCR ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED 1/21/2022: AFTER INSERTING THE SWIVELOCK AND COMPLETING THE SPEEDBRIDGE REPAIR, THE INTERNAL WIRES OF THE ANCHOR BROKE AND SURGEON HAD TO USE AN AR-7201 FIBERWIRE TO REINFORCE THE SUTURES. THE ANCHOR AND EYELET REMAIN IMPLANTED SUCCESSFULLY INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220950 ↗
• InjuryJan 11, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ON 12/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (3) AR-2324BCC-2 BIOCOMPOSITE SWIVELOCK C WAS USED DURING A PROXIMAL HAMSTRING REPAIR PROCEDURE ON (B)(6) 2021. THE PATIENT HAS BEEN EXPERIENCING CYSTIC FORMATION, DRAINAGE FROM THE ANCHOR SITE, AND PAIN. THE PATIENT REQUIRED ADDITIONAL WASHOUT OF THE INFECTED AREA. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Abscess

  MAUDE report 18497270 ↗
• InjuryJan 11, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED ON 1/17/2024: THE PATIENT STARTED TO EXPERIENCE SYMPTOMS ABOUT TWELVE TO SIXTEEN MONTHS AFTER THE PROCEDURE WAS PERFORMED. CULTURES WERE TAKEN FROM THE INFECTION SITE, AND DESPITE THE INTENSIVE REVIEW FROM THE INFECTIOUS DISEASE PHYSICIAN, THE RESULTS CAME BACK NEGATIVE. THE PATIENT HAS UNDERGONE TWO INCISIONS AND DRAINAGE PROCEDURES DUE TO THE RECURRING INFECTIONS. THE PATIENT IS CURRENTLY STILL BEING TREATED FOR INFECTIONS AND DRAINAGE. AT THIS TIME, NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Abscess

  MAUDE report 18495828 ↗
• InjuryJan 11, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED ON 1/17/2024: THE PATIENT STARTED TO EXPERIENCE SYMPTOMS ABOUT TWELVE TO SIXTEEN MONTHS AFTER THE PROCEDURE WAS PERFORMED. CULTURES WERE TAKEN FROM THE INFECTION SITE, AND DESPITE THE INTENSIVE REVIEW FROM THE INFECTIOUS DISEASE PHYSICIAN, THE RESULTS CAME BACK NEGATIVE. THE PATIENT HAS UNDERGONE TWO INCISIONS AND DRAINAGE PROCEDURES DUE TO THE RECURRING INFECTIONS. THE PATIENT IS CURRENTLY STILL BEING TREATED FOR INFECTIONS AND DRAINAGE. AT THIS TIME, NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Abscess

  MAUDE report 18495824 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/18/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1400TB BIO-INTERFERENCE SCREW FULL THREAD, AN AR-1588T ACL TIGHTROPE, (3) AR-2324BCC-2 BIO COMPOSITE SWIVELOCK, (3) AR-4500 MENISCAL CINCH, (4) AR-7200 FIBERWIRE, AND (2) AR-7237 FIBERTAPE WERE ALL IMPLANTED IN THE PATIENT. THIS ACL AND LIGAMENT PROCEDURE TOOK PLACE ON (B)(6) 2023. PATIENT DEVELOPED AN INFECTION POST OPERATIVE AND PATIENT REMAINS ADMITTED TO THE HOSPITAL FOR TREATMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 16302975 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/18/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1400TB BIO-INTERFERENCE SCREW FULL THREAD, AN AR-1588T ACL TIGHTROPE, (3) AR-2324BCC-2 BIO COMPOSITE SWIVELOCK, (3) AR-4500 MENISCAL CINCH, (4) AR-7200 FIBERWIRE, AND (2) AR-7237 FIBERTAPE WERE ALL IMPLANTED IN THE PATIENT. THIS ACL AND LIGAMENT PROCEDURE TOOK PLACE ON (B)(6) 2023. PATIENT DEVELOPED AN INFECTION POST OPERATIVE AND PATIENT REMAINS ADMITTED TO THE HOSPITAL FOR TREATMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 16302970 ↗
• MalfunctionFeb 28, 2022Material Frayed

  ON 2/7/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324BCC-2 SWIVELOCK ANCHOR FRAYED AND PRODUCED DEBRIS WHEN IT WAS INSERTED ABOUT HALF WAY DOWN THE BONE. SURGEON USED AN AR-1927PBS PUNCH TO PREP THE BONE SOCKET FOR THE ANCHOR AND LOADED AN AR-7501 SUTURETAPE INTO THE EYELET OF THE ANCHOR. WHEN SURGEON HAD INSERTED THE ANCHOR, ABOUT HALF WAY DOWN, THE ANCHOR STARTED PEELING LIKE A PENCIL IN A PENCIL SHARPENER. SURGEON WAS ABLE TO TWIST OUT AND REMOVE BOTH THE ANCHOR AND DEBRIS. A SECOND BONE HOLE WAS CREATED USING AN AR-2324PTB TAP AND AN AR-2324BCC-2 SWIVELOCK ANCHOR WAS INSERTED TO COMPLETE CASE. NO FURTHER ISSUES HAS BEEN REPORTED. THIS WAS DISCOVERED DURING A SUPRASPINATUS TENDON REPAIR.

  Patient problems: Insufficient Information

  MAUDE report 13619234 ↗
• MalfunctionAug 3, 2021Material Frayed; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SUBSCAP REPAIR, AFTER BOTH DBL LOADED ANCHORS WERE PLACED, THE SURGEON THEN PASSED THE FIRST SUTURE AND NOTICED THAT THE MIDDLE OF THE SUTURE WAS FRAYED. ONCE THE SURGEON PULLING ON THE SUTURE FULLY, THE AR-2324BCC-2 TORE. THE SURGEON THEN MOVED TO THE SECOND ANCHOR AND NOTICED FRAYING A LITTLE HIGHER ON THE SUTURE. THE SURGEON WAS ABLE TO CUT AND REMOVE THE DAMAGED SECTION WITHOUT FURTHER ISSUE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267458 ↗
• MalfunctionMay 10, 2021Flaked; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SUTURES WERE FRAYED AND CAUSED THE EYELET TO DETACH DURING INSERTION. THIS OCCURRED WITH THE FIRST TWO ATTEMPTS; THEY WERE SUCCESSFUL ON THE THIRD INSERTION. THE EYELETS WERE RETRIEVED FROM THE PATIENT WITH A GRASPER AND THE CASE WAS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 11801026 ↗
• MalfunctionMay 10, 2021Flaked; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SUTURES WERE FRAYED AND CAUSED THE EYELET TO DETACH DURING INSERTION. THIS OCCURRED WITH THE FIRST TWO ATTEMPTS; THEY WERE SUCCESSFUL ON THE THIRD INSERTION. THE EYELETS WERE RETRIEVED FROM THE PATIENT WITH A GRASPER AND THE CASE WAS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 11801012 ↗