Arthrex® AR-2324PSLCRecalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00888867026919), received between Jul 19, 2016 and Sep 28, 2026 — classified as 17 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Break” (58 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 25 most recent of 101 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  On 10-Sep-2026, it was reported by an Arthrex Subsidiary Employee via (b)(6)that an AR-2324PSLC Suture Anchor, PEEK-SwiveLock broke during insertion. It was reported that during anchor insertion, there was a change in the surgeon's hand positioning that resulted in the anchor breaking. This was discovered during an Elbow Triceps Repair procedure with no patient harm. No fragment remained in the patient. There was no delay in the procedure, and no additional anesthesia was required. The case was completed with another anchor.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915119 ↗
• MalfunctionSep 16, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790296 ↗
• MalfunctionSep 2, 2026Break

  Additional information provided 10-Sep-2026: It was further reported this occurred during an Ankle Instability procedure with no patient harm. No procedural delay was experienced, and no additional anesthesia was necessary. The case was completed with another anchor.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570304 ↗
• MalfunctionJul 27, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024330 ↗
• MalfunctionMay 28, 2026Material Frayed

  IT WAS REPORTED THAT DURING A FOOT SURGERY THE SUTURE WAS FRAYED. THE DEFECT WAS NOTICED AFTER IMPLANTATION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE DEVICE. THE DEFECTIVE SUTURE WAS NOT USED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25316164 ↗
• MalfunctionMay 28, 2026Material Frayed

  IT WAS REPORTED THAT DURING A FOOT SURGERY THE SUTURE WAS FRAYED. THE DEFECT WAS NOTICED AFTER IMPLANTATION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE DEVICE. THE DEFECTIVE SUTURE WAS NOT USED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25316161 ↗
• MalfunctionMar 25, 2026Positioning Failure

  ON 5TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-2324PSLC, SUTURE ANCHOR, PEEK-SWIVELOCK® C, 4.75 X 19.1 MM, VENTED, THE ANCHOR COULD NOT BE SET SUCCESSFULLY. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER NEW AR-2324PSLC WAS USED. AR-1927PB AND AR-2324PTB WERE USED TO PREPARE THE BONE SOCKET. THE BONE QUALITY OF PATIENT WAS SOFT AND NO FRAGMENTS WERE FOUND. 13 MARCH 2026 - THE COMPLAINT INITIATOR REPLIED THAT THE ANCHOR COULD NOT BE FULLY IMPLANTED, SO THE SURGEON NEEDED TO REPLACE A NEW ANCHOR TO COMPLETE THE PROCEDURE. HE CONFIRMED THAT THE ANCHOR WAS DEPLOYED SUCCESSFULLY, BUT IMPLANT DID NOT SEAT.

  Patient problems: Insufficient Information

  MAUDE report 24688606 ↗
• MalfunctionMar 17, 2026Break

  ON 24TH FEB 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-2324PSLC, SUTURE ANCHOR, PEEK-SWIVELOCK® C, 4.75 X 19.1 MM, VENTED, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A REPAIR OF ELBOW JOINT LIGAMENTS SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY CHANGING TO A NEW AR-2324PSLC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615801 ↗
• MalfunctionMar 17, 2026Break

  ON 24TH FEB 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-2324PSLC, SUTURE ANCHOR, PEEK-SWIVELOCK® C, 4.75 X 19.1 MM, VENTED, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A REPAIR OF ELBOW JOINT LIGAMENTS SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY CHANGING TO A NEW AR-2324PSLC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615682 ↗
• InjuryMar 12, 2026Patient Device Interaction Problem

  ON 19-FEB-2026, IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL VIA EMAIL THAT A PATIENT WHO HAD UNDERGONE SURGERY DURING WHICH AN AR-2324PSLC PEEK-SWIVELOCK WAS IMPLANTED EXPERIENCED POSTOPERATIVE DISCOLORATION AND TWITCHING. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 02-MAR-2026: THE PATIENT'S SURGICAL PROCEDURE OCCURRED ON (B)(6)2025. NO OTHER ARTHREX PRODUCTS WERE USED DURING THE PROCEDURE. ACCORDING TO THE HEALTH CARE PROFESSIONAL, THE PATIENT BEGAN EXPERIENCING SYMPTOMS IMMEDIATELY FOLLOWING THE SURGERY. THE PATIENT HAS SINCE BEEN EVALUATED BY MULTIPLE MEDICAL PROVIDERS AND HAS ATTENDED PHYSICAL THERAPY, AS WELL AS UNDERGONE HYDRODISSECTION. THE REPORTED ONGOING SYMPTOMS INCLUDE TWITCHING, DISCOLORATION, AND LACK OF SENSATION IN THE HAND, WITH NO IMPROVEMENT NOTED. THERE ARE NO REPORTED ALLERGIES PRIOR TO THE EVENT AND NO SIGNS OF INFECTION. AT THIS TIME, NO REMOVAL OR REVISION HAS BEEN DISCUSSED.

  Patient problems: Nerve Damage

  MAUDE report 24580486 ↗
• InjuryFeb 19, 2026Patient Device Interaction Problem

  ON 04-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324PSLC PEEK SWIVELLOCK WAS USED IN A LOOP AND TAK TENDONESIS ON (B)(6) 2025 AND COMPLETED PROCEDURE SUCCESSFULLY. THE PATIENT COMPLAINED 9 WEEKS AFTER SURGERY OF NUMBNESS. PATIENT WAS NEGATIVE FOR DVT AND WAS DIAGNOSED WITH ULNAR NEURITIS. PATIENT COMPLAINS OF UPPER EXTREMITY PAIN AND SELF-DIAGNOSED DISCOLORATION. PATIENT REQUESTED A SAMPLE OF THE PEEK SWIVELLOCK TO BE SENT TO THE ALLERGIST FOR TESTING. PATIENT HAS BEEN FREQUENTLY COMPLAINING OF VARIOUS NON-ANATOMICALLY RELATED PAIN AND DISCOMFORT. NO REVISION SURGERY HAS BEEN SCHEDULED.

  Patient problems: Discomfort; Numbness; Pain

  MAUDE report 24393271 ↗
• MalfunctionFeb 10, 2026Material Deformation

  ON 21ST JAN 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2324PSLC, SUTURE ANCHOR, PEEK-SWIVELOCK® C, 4.75 X 19.1 MM, VENTED, ITS ANCHOR DEFORMED DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-2324PSLC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303384 ↗
• MalfunctionDec 29, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324PSLC PEEK SWIVELOCK ANCHOR BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A SUBSCAPULARIS REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 11-DEC-2025: DURING THE PROCEDURE, ALL FRAGMENTS RELATED TO THE ISSUE WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. TO COMPLETE THE CASE, A NEW AR-2324PSLC PEEK SWIVELOCK WAS USED. THE EVENT RESULTED IN AN APPROXIMATE THREE-MINUTE DELAY. IT IS UNKNOWN WHETHER ANY ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23906426 ↗
• MalfunctionDec 24, 2025Break; Break

  ON 6TH DEC 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2324PSLC, SUTURE ANCHOR, PEEK-SWIVELOCK® C, 4.75 X 19.1 MM, VENTED, PART OF THE SCREW CAME OFF. THIS WAS DETECTED DURING AN ACL SECONDARY FIXATION (IB) ON 4TH DEC 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REMOVING THE SCREW REMNANT AND THE SECONDARY FIXATION WAS STABLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888680 ↗
• MalfunctionNov 24, 2025Break; Break

  ON 5TH NOV 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2324PSLC, SUTURE ANCHOR, PEEK-SWIVELOCK® C, 4.75 X 19.1 MM, VENTED, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER AR-2324PSLC WITH THE SAME LOT. THERE WERE NO PATIENT HARM AND NO SECONDARY SURGERY NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632888 ↗
• InjuryNov 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 10/29/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN INFECTION HAD OCCURRED AT A SURGERY CENTER. IT WAS NOTED THAT TWO INFECTIONS WERE ASSOCIATED WITH THE SAME AR NUMBER AND LOT NUMBER: AR-2324PSLC PEEK SWIVELOCK C SUTURE ANCHOR, LOT: 15424184. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 11/03/2025.

  Patient problems: Unspecified Infection

  MAUDE report 23603873 ↗
• InjuryNov 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN INFECTION HAD OCCURRED AT A SURGERY CENTER. IT WAS NOTED THAT TWO INFECTIONS WERE ASSOCIATED WITH THE SAME AR NUMBER AND LOT NUMBER: AR-2324PSLC PEEK SWIVELOCK C SUTURE ANCHOR, LOT 15424184. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 11/03/2025.

  Patient problems: Unspecified Infection

  MAUDE report 23603752 ↗
• MalfunctionOct 27, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 10/15/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-2324PSLC PEEK SWIVELOCK SUTURE ANCHOR GOT STUCK, SO A SECOND ANCHOR HAD TO BE OPENED TO COMPLETE THE TRICEPS TENDON REPAIR. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391937 ↗
• MalfunctionOct 24, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2324PSLC, SUTURE ANCHOR, PEEK-SWIVELOCK® C, 4.75 X 19.1 MM, VENTED, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR AND RECONSTRUCTION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-2324PSLC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378401 ↗
• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT BACK UP FIXATION SURGERY THE PEEK SWIVELOCK AR-2324PSLC BROKE INSIDE PATIENT WHEN SURGEON WAS INSERTING THE SWIVELOCK AFTER DRILLING AND TAPPING THE SOCKET. PEEK SWIVELOCK SNAPPED DISTALLY BUT SURGEON HAPPY WITH THE FIXATION. THE PART THAT WAS LEFT IN THE PATIENT WAS STABLE AND HOLDING THE SUTURES OF THE BACK UP FIXATION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23366240 ↗
• MalfunctionOct 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/10/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-7221 FIBERWIRE #2-0 AND AN AR-2324PSLC PEEK SWIVELOCK C SUTURE ANCHOR CAME OUT OF THE HOLE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/15/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334940 ↗
• MalfunctionAug 20, 2025Break; Failure to Advance; Break; Failure to Advance

  ON 4TH AUGUST 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR 1 UNIT OF AR-2324PSLC, SUTURE ANCHOR, PEEK-SWIVELOCK® C, 4.75 X 19.1 MM, VENTED, ITS ANCHOR BREAK DURING INSERTION. THIS WAS DETECTED DURING A LATERAL COLLATERAL LIGAMENT REPAIR SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-2324PSLC. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850804 ↗
• MalfunctionAug 8, 2025Break; Break

  ON 23RD JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT 1 UNIT OF AR-2324PSLC, SUTURE ANCHOR, PEEK-SWIVELOCK® C, 4.75 X 19.1 MM, VENTED, AND 1 UNIT OF AR-7237-7, FIBERTAPE® 2 MM, BRAIDED POLYBEND SUTURE, BLUE, WAS USED TO IMPLANT BUT THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING AN ANKLE ARTHROSCOPIC LIGAMENT REPAIR AND REINFORCEMENT SURGERY ON (B)(6) 2025. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER BRAND PRODUCT. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751847 ↗
• MalfunctionAug 4, 2025Break; Break

  ON 07/16/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-2324PSLC SUTURE ANCHOR BROKE. THIS OCCURRED DURING THE FIXATION IN TIBIA WITH FIBERTAPE, IT OCCUPIES A TAP (AR-1927D) TO MAKE THE TUNNEL, UNTIL THAT MOMENT EVERYTHING WENT WELL, THEY INTRODUCED THE EYELET AND THE FIRST PART OF THE STEM BUT AT THE MOMENT THAT THE SCREW ENTERED THIS ONE DID NOT ENTER ALTHOUGH IT LOWERED ALL THE GREEN HANDLE, THEY TRIED A SECOND TIME ASSEMBLING THE ANCHOR AGAIN AND THE SAME THING HAPPENED AND ALSO PART OF THE SCREW BROKE, THEY CONTINUED WITH ANOTHER PART OF THE SURGERY (EPM), AND WHEN HE RETURNED TO THIS FIXATION THEY ALSO USED A SWIVELOCK MALE AND ENDED UP FIXING WITH A TITANIUM TIP SWIVELOCK AND A PEEK SCREW, AND THERE WAS NO PROBLEM.

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

  MAUDE report 22704668 ↗
• MalfunctionJul 7, 2025Break; Break

  ON 10TH JUNE 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT 2 UNITS OF AR-2324PSLC, SUTURE ANCHOR, PEEK-SWIVELOCK® C, 4.75 X 19.1 MM, VENTED, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A LATERAL COLLATERAL LIGAMENT REPAIR SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY CHANGING TO A NEW AR-2324PSLC. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22411482 ↗