Arthrex® AR-2323KBCSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867384453), received between Sep 15, 2023 and May 7, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 18, 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.

• MalfunctionMay 7, 2025Break; Break

  ON 04/09/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-2323KBCSP KNOTLESS BIOCOMPOSITE SWIVELOCK SP HAD THE PEEK EYELET SNAPPED OFF DURING A COMPETITIVE TRIAL. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED. THIS WAS DISCOVERED DURING A SUBSCAP REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21980084 ↗
• MalfunctionNov 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/25/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2323KBCSP KNOTLESS BIOCOMPOSITE SELF-PUNCHING SWIVELOCK EYELET DISLODGED WHEN IT WAS MALLETED IN FOR INSERTION. PRIOR TO THE INSERTION OF THE SWIVELOCK, THE SURGEON PREPARED THE BONE SOCKET WITH AN INSTRUMENT FROM ANOTHER MANUFACTURER. THE SURGEON OPTED TO INSERT THE ANCHOR WITHOUT A PUNCH AS THE PATIENT HAD VERY STRONG BONES. UPON MALLETING THE ANCHOR, THE EYELET DISLODGED. THE SURGEON RELOADED THE EYELET, HELD THE SUTURES TIGHT TO THE INSERTER WITH A HEMOSTAT, AND ATTEMPTED TO INSERT THE ANCHOR AGAIN, BUT IT WAS UNSUCCESSFUL. THE SURGEON OPENED A SECOND AR-2323KBCSP KNOTLESS BIOCOMPOSITE SELF-PUNCHING SWIVELOCK. THE EYELET ON THE SECOND ANCHOR ALSO POPPED OFF. THE BROKEN FRAGMENTS FROM BOTH SWIVELOCKS WERE SUCCESSFULLY REMOVED FROM THE PATIENT. AN IMPLANT FROM ANOTHER MANUFACTURER WAS ATTEMPTED TO BE USED, BUT IT WAS ALSO UNSUCCESSFUL. THE SURGEON THEN DETERMINED THAT THE BONE WAS VERY HARD AND PREPARED A PUNCH HOLE USING A 4.5MM ARTHREX PUNCH/AWL. AFTER THIS PROCESS, A 4.75MM KNOTLESS SWIVELOCK WAS BENT. AFTER ADJUSTING THE ANGLE, THE SURGEON COMPLETED THE REPAIR USING TWO 4.75MM SWIVELOCKS. THIS WAS D

  Patient problems: Insufficient Information

  MAUDE report 20634674 ↗
• MalfunctionNov 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/25/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2323KBCSP KNOTLESS BIOCOMPOSITE SELF-PUNCHING SWIVELOCK EYELET DISLODGED WHEN IT WAS MALLETED IN FOR INSERTION. PRIOR TO THE INSERTION OF THE SWIVELOCK, THE SURGEON PREPARED THE BONE SOCKET WITH AN INSTRUMENT FROM ANOTHER MANUFACTURER. THE SURGEON OPTED TO INSERT THE ANCHOR WITHOUT A PUNCH AS THE PATIENT HAD VERY STRONG BONES. UPON MALLETING THE ANCHOR, THE EYELET DISLODGED. THE SURGEON RELOADED THE EYELET, HELD THE SUTURES TIGHT TO THE INSERTER WITH A HEMOSTAT, AND ATTEMPTED TO INSERT THE ANCHOR AGAIN, BUT IT WAS UNSUCCESSFUL. THE SURGEON OPENED A SECOND AR-2323KBCSP KNOTLESS BIOCOMPOSITE SELF-PUNCHING SWIVELOCK. THE EYELET ON THE SECOND ANCHOR ALSO POPPED OFF. THE BROKEN FRAGMENTS FROM BOTH SWIVELOCKS WERE SUCCESSFULLY REMOVED FROM THE PATIENT. AN IMPLANT FROM ANOTHER MANUFACTURER WAS ATTEMPTED TO BE USED, BUT IT WAS ALSO UNSUCCESSFUL. THE SURGEON THEN DETERMINED THAT THE BONE WAS VERY HARD AND PREPARED A PUNCH HOLE USING A 4.5MM ARTHREX PUNCH/AWL. AFTER THIS PROCESS, A 4.75MM KNOTLESS SWIVELOCK WAS BENT. AFTER ADJUSTING THE ANGLE, THE SURGEON COMPLETED THE REPAIR USING TWO 4.75MM SWIVELOCKS. THIS WAS D

  Patient problems: Insufficient Information

  MAUDE report 20633546 ↗
• MalfunctionSep 15, 2023Unintended Movement; Unintended Movement

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2323KBCSP SWIVELOCK KNOTLESS MECHANISM IN THE ANCHOR EYELET DID NOT HOLD FIXATION. THIS OCCURRED AGAIN WITH THE SECOND AR-2323KBCSP SWIVELOCK THAT WAS OPENED. THE CASE WAS COMPLETED WITH THE ANCHORS IMPLANTED IN THE PATIENT HOLDING SUTURES FROM THE MEDIAL ROW OF THE SPEED BRIDGE REPAIR AND BY CUTTING THE REPAIR STITCHES FROM THE KNOTLESS MECHANISM AND INSERTING A FIBERTAK TO TIE DOWN THE DOG EARS. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 17757682 ↗