Arthrex® AR-2323KPSLCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867351349), received between Apr 25, 2022 and May 2, 2025 — classified as 1 injury, 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Positioning Failure; Positioning Failure

  ON 04/21/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-2323KPSLC PEEK KNOTLESS SWIVELOCK® SUTURE ANCHORS SUTURES PULLED THROUGH THE TIP OR THE PEEK AS THEY IMPLANTED IT. THIS OCCURRED DURING A CASE. THE FIXATION WAS ABLE TO BE LOCKED IN HOWEVER THE SUTURES WERE UNABLE TO BE UTILIZED DUE TO BEING DEFECTIVE. THERE WAS A LESS THAN FIVE MINUTE DELAY THAT REQUIRED ADDITIONAL ANESTHESIA FOR JUST THOSE FIVE. THERE WAS NO HARM ON THE PATIENT. THIS OCCURRED DURING A CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950492 ↗
• MalfunctionMay 2, 2025Positioning Failure; Positioning Failure

  ON 04/21/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-2323KPSLC PEEK KNOTLESS SWIVELOCK® SUTURE ANCHORS SUTURES PULLED THROUGH THE TIP OR THE PEEK AS THEY IMPLANTED IT. THIS OCCURRED DURING A CASE. THE FIXATION WAS ABLE TO BE LOCKED IN HOWEVER THE SUTURES WERE UNABLE TO BE UTILIZED DUE TO BEING DEFECTIVE. THERE WAS A LESS THAN FIVE MINUTE DELAY THAT REQUIRED ADDITIONAL ANESTHESIA FOR JUST THOSE FIVE. THERE WAS NO HARM ON THE PATIENT. THIS OCCURRED DURING A CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950035 ↗
• MalfunctionApr 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-2323KPSLC PEEK KNOTLESS SWIVELOCK FAILED DURING USE. THE FIRST SWIVELOCK FAILURE OCCURRED WHEN THE LOCKING MECHANISM DID NOT HOLD, COMPROMISING THE FUNCTIONALITY OF THE DEVICE. THE SECOND SWIVELOCK FAILURE INVOLVED AN ISSUE WITH THE SUTURE ON THE LOOP, WHERE IT BUNCHED UP AND WAS UNABLE TO PASS THROUGH THE ANCHOR AS INTENDED. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 4/19/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935097 ↗
• MalfunctionApr 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-2323KPSLC PEEKS KNOTLESS SWIVELOCK FAILED DURING USE. THE FIRST SWIVELOCK FAILURE OCCURRED WHEN THE LOCKING MECHANISM DID NOT HOLD, COMPROMISING THE FUNCTIONALITY OF THE DEVICE. THE SECOND SWIVELOCK FAILURE INVOLVED AN ISSUE WITH THE SUTURE ON THE LOOP, WHERE IT BUNCHED UP AND WAS UNABLE TO PASS THROUGH THE ANCHOR AS INTENDED. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 4/19/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935088 ↗
• MalfunctionApr 10, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE SUTURE WOULD NOT DEPLOY WITH THE ANCHOR. ANOTHER (B)(6) WAS USED TO COMPLETE THE CASE; BICEPS TENODESIS.

  Patient problems: Insufficient Information

  MAUDE report 19082002 ↗
• InjuryApr 25, 2022Structural Problem

  SURGEON WAS PERFORMING A DOUBLE ROW ROTATOR CUFF REPAIR USING AR-1927PSF-475 MEDIALLY AND AR2323KPSLC LATERALLY. HE HAS RECENTLY BEEN TRIALING THE AR-2323KPSLC (KNOTLESS SWIVELOCK). AFTER COMPLETING THE MAJORITY OF HIS DOUBLE ROW REPAIR, HE TENSIONED HIS SUTURE TAPES THAT HAD BEEN DUNKED IN THE SWIVELOCKS EYELET INTO THE PUNCHED LATERAL HOLE. TWO OF HIS SUTURE TAPES SNAPPED RIGHT AT THE EYELET (IN THE BOTTOM OF THE PUNCHED SWIVELOCK HOLE) AND CAME LOOSE. THIS COMPLETELY DE THREADED HIS DOUBLE ROW REPAIR WITH THE SURGERY ALMOST COMPLETE. THE ANCHORS REMAINED IN SITU AND HE COMPLETED THE ROTATOR CUFF REPAIR WITH AN OPEN APPROACH. AFTER THE CASE WE INSPECTED THE EYELET OF THE KNOTLESS SWIVELOCK IN A STERILE PACKET AND COMPARED IT THE REGULAR SWIVELOCK EYELET. WE NOTICED THERE IS A BREAK IN THE ROUNDED PLASTIC EYELET TO ALLOW FOR THE KNOTLESS MECHANISM. THIS BREAK ALSO EXPOSES THE METAL INSERTER. WE BELIEVE THAT THIS SMALL GAP MADE THE EYE LIT MUCH SHARPER THAN THE REGULAR VERSION CAUSING THE SUTURE TAPES TO SNAP. IN THE NEXT CASE HE DID HIS REGULAR DOUBLE ROW ROTATOR CUFF REPAIR WITH A REGULAR SWIVELOCK AND THERE WAS NO ISSUE, THUS RULING OUT A TECHNIQUE ISSUE. HE HAS DONE HUNDREDS OF

  Patient problems: Laceration(s)

  MAUDE report 14192977 ↗