Arthrex® AR-2323BCMRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867026735), received between Nov 9, 2017 and Sep 12, 2023 — classified as 1 injury, 2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 9/17/2024: THIS WAS DISCOVERED DURING AN RCR PROCEDURE. AFTER USING THE MALLET TO KNOCK THE ANCHOR INTO THE LASER LINE, THE ANCHOR STARTED TO ADVANCE INTO THE BONE THEN THE ANCHOR SPLIT VERTICALLY DOWN THE MIDDLE. IT WAS THEN STRIPPED. THE ENTIRE ANCHOR WAS ABLE TO BE PULLED OUT. NOTHING WAS LEFT BEHIND. THE CASE WAS COMPLETED USING AN AR-2323BCM BIO-COMPOSITE SWIVELOCK SP. THE BONE WAS NORMAL TO SOFT QUALITY. THE SURGEON HAD TO USE A BIGGER ANCHOR MEDIAL BECAUSE THE BONE QUALITY WASN¿T VERY GOOD. THE CASE ONLY DELAYED ABOUT THIRTY SECONDS.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17731828 ↗
• MalfunctionFeb 7, 2022Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT A AR-2323BCM SUTURE ANCHOR BROKE. THIS OCCURRED ON (B)(6) 2021 DURING A PROCEDURE WHEN THE SURGEON WAS INSERTING THE ANCHOR THE BIOCOMPOSITE SECTION OF THE ANCHOR BROKE. THE BONE QUALITY OF THE PATIENT WAS GOOD, BUT NOT EXTREMELY HARD. THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 12/01/2021 : THE PROCEDURE BEING PERFORMED WAS A ROTATOR CUFF. THE DEVICE BROKE DURING THE PROCEDURE, AND ALL FRAGMENTS WERE REMOVED. NO INSTRUMENT WAS USED TO PREPARE THE BONE SOCKET AS THE 2323BCM IS SELF PUNCHING. THE CASE WAS COMPLETED USING A AR-2323BCT-2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471113 ↗
• InjuryNov 9, 2017Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2017. ON THE 2ND. WEEK POST-OP FOLLOW UP APPOINTMENT, AN X-RAY CONFIRMED THAT THE METAL TIP OF THE DEVICE HAD BACKED OUT OF THE PATIENT'S BONE. A REVISION SURGERY WAS SCHEDULED AND COMPLETED ON (B)(6) 2017. UPON ENTERING THE SURGICAL SITE, THE SURGEON REALIZED THAT THE BIO-COMPOSITE SWIVELOCK ANCHOR WAS SHATTERED. ALL FRAGMENTS OF THE ANCHOR WERE REMOVED WITH A GRASPER AND WAS REPLACED WITH FIBERTAPE AND THE SURGEON DID A BONE TUNNEL WITH A PROLENE MESH WHEN TYING OVER THE BONE. THE REP NOTED THAT THE PATIENT'S BONE WAS BRITTLE. PATIENT IS A FEMALE, (B)(6). FOLLOW-UP INVESTIGATION: THE AR-2323BCM IS A BIO-COMPOSITE ANCHOR THAT IS SELF PUNCHING AND HAS A METAL TIP. ALL BROKEN PIECES WERE RETRIEVED DURING THE REVISION AND ARE BEING RETURNED TO ARTHREX FOR EVALUATION. NO FALL OR PATIENT INJURY WAS REPORTED PRIOR TO THE POST OP X-RAY.

  Patient problems: No Code Available

  MAUDE report 7014199 ↗