Arthrex® AR-2323BCSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867384439), received between Dec 21, 2023 and Sep 11, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Break

  On 31st August 2026, it was reported by an Arthrex employee via email that for an: 1. (AR-2324BCSP, 4.75 mm BioComposite SwiveLock® Anchor, Self Punching With White/Blue 1.3 mm SutureTape Lot:15441583 ) the PEEK tip broke during insertion. The bone quality was normal. 2. (AR-2323BCSP, 5.5 mm BioComposite SwiveLock® Anchor, Self Punching With White/Blue 1.3 mm Suture Tape, VE5 Lot:15399119) an attempt was made to insert the anchor using the self-punching technique, but insertion was unsuccessful. Upon removing the anchor, it was discovered that the PEEK tip was missing. As the tip was caught on the tape that had been passed through the rotator cuff, it had to be retrieved. Inspection of the device revealed that the tape securing the PEEK tip had snapped. This was detected during use in an unknown procedure on (b)(6) 2026. The procedure was completed successfully by using a product with the same part number. No significant surgery delay reported. All of the product/fragment was removed and nothing remains in the patient. No additional anesthesia administered to the patient. No information about an instrument used to prepare/tap the bone socket for insertion of the implant.

  Patient problems: Insufficient Information

  MAUDE report 50732449 ↗
• MalfunctionJan 23, 2026Material Split, Cut or Torn

  ON 08-JAN-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-2323BCSP BIOCOMPOSITE SELF-PUNCHING SWIVELOCK ANCHOR EXPERIENCED A TIP PEEK EYELET SPLIT VERTICALLY WHEN HAMMERED IN WITHOUT DRILLING A PILOT HOLE. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-2323BCSP BIOCOMPOSITE SELF-PUNCHING SWIVELOCK WITHOUT ISSUE. THIS EVENT OCCURRED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2026. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED. NO BROKEN FRAGMENTS REMAINED IN THE PATIENT. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING OR FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163511 ↗
• MalfunctionMar 12, 2024Break; Break

  ON 02/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE EYELET FROM AN AR-2323BCSP SELF PUNCHING BIOCOMPOSITE SWIVELOCK BROKE. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 03/01/2024, WHERE THE SALES REPRESENTATIVE REPORTED THE DEVICE DID BREAK INSIDE THE PATIENT, AND ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED USING AN AR-2323BCSP SWIVELOCK. THE PATIENT HAD A HARD BONE THAT WAS NOT PREPPED WITH AN INSTRUMENT.

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

  MAUDE report 18887963 ↗
• MalfunctionDec 21, 2023Break; Break

  ON 11/22/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2323BCSP BIOCOMPOSITE SWIVELOCK EYELET BROKE IN HALF ON THE FIRST MALLET STRIKE. THIS WAS DISCOVERED DURING AN RCR PROCEDURE. ALL BROKEN FRAGMENTS WERE REMOVED FROM INSIDE THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 11/29/2023: THE PROCEDURE TOOK PLACE ON (B)(6) 2023 AND WAS COMPLETED USING AN AR-2323BCT-2 BIOCOMPOSITE SWIVELOCK. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18375859 ↗