Arthrex® AR-2325PSLCRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00888867026971), received between Dec 13, 2021 and Dec 24, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2325PSLC, SUTURE ANCHOR, PEEK SWIVELOCK®, 3.5 MM X 15.8 MM, VENTED, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A RIGHT DELTOID LIGAMENT OF THE ANKLE SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-2325PSLC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888133 ↗
• MalfunctionDec 1, 2025Damaged Thread; Damaged Thread

  IT WAS REPORTED DURING THE ARTHROSCOPY THAT THE THREAD OF THE MIDDLE ON THE ANCHOR WAS STRIPPED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680174 ↗
• MalfunctionOct 17, 2025Break; Defective Device; Material Deformation; Break; Defective Device; Material Deformation

  ON 10/09/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2325PSLC PEEK LABRAL SWIVELOCK SUTURE ANCHOR AND AN AR-2326PSLC PEEK SWIVELOCK ANCHOR WERE MISSHAPED AND BROKE UPON INSERTION. NO FURTHER DETAILS WERE PROVIDED. THE ISSUE WAS IDENTIFIED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/10/2025.

  Patient problems: Insufficient Information

  MAUDE report 23328415 ↗
• MalfunctionJul 24, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-2325PSLC, SUTURE ANCHOR, PEEK SWIVELOCK®, 3.5 MM X 15.8 MM, VENTED, 1 UNIT OF AR-2325PSLC'S ANCHOR BROKE DURING INSERTION. HENCE, THE SURGEON CHANGED TO ANOTHER NEW AR-2325PSLC. BUT THE 2ND AR-2325PSLC'S ANCHOR DROPPED OUT TOO. THIS WAS DETECTED DURING AN ANKLE LIGAMENT INJURY REPAIR SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING AR-2324BCC. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588768 ↗
• MalfunctionJul 24, 2025Break; Break

  ON 2ND JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-2325PSLC, SUTURE ANCHOR, PEEK SWIVELOCK®, 3.5 MM X 15.8 MM, VENTED, 1 UNIT OF AR-2325PSLC'S ANCHOR BROKE DURING INSERTION. HENCE, THE SURGEON CHANGED TO ANOTHER NEW AR-2325PSLC. BUT THE 2ND AR-2325PSLC'S ANCHOR DROPPED OUT TOO. THIS WAS DETECTED DURING AN ANKLE LIGAMENT INJURY REPAIR SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING AR-2324BCC. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588737 ↗
• MalfunctionMay 29, 2025Break; Break

  ON 05/06/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-2325PSLC SUTURE ANCHOR EXPERIENCED A SCREW BREAKAGE UPON INITIAL INSERTION WHEN STARTING TO SCREW. THE CASE WAS COMPLETED BY OPENING A NEW PRODUCT. THERE WERE NO REPORTS OF FRAGMENTS BREAKING OFF INSIDE THE PATIENT. NO FURTHER CASE DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING A PATELLAR RUPTURE ARTHROSCOPY PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104571 ↗
• MalfunctionApr 17, 2025Failure to Advance; Failure to Advance

  ON 3/25/2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-2325PSLC PEEK SWIVELOCK EYELET DOES NOT SCREW INTO THE METAL INSERTER TIP. THIS WAS DISCOVERED DURING A LATERAL ANKLE INSTABILITY PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855227 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE JOINT SURGERY THE FRONT SREW CONNECTION BROKE OFF. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY.THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE AR-1928SF-45. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143387 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE JOINT SURGERY THE FRONT SCREW CONNECTION BROKE OFF. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE AR-1928SF-45. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143384 ↗
• MalfunctionJul 24, 2024Break; Break

  ON 06/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-1926BCSP BIOCOMPOSITE PUSHLOCKS AND AN AR-2325PSLC PEEK SWIVELOCK HAD ISSUES. THE FIRST AR-1926BCSP BIOCOMPOSITE PUSHLOCK EYELET BENT AND BROKE OFF THE INSERTER WHEN IT WAS BEING MALLETED DOWN. THE SECOND AR-1926BCSP BIOCOMPOSITE PUSHLOCK WAS MALLETED DOWN, BUT IT WAS DIFFICULT TO BREACH THE CORTICAL SURFACE OF THE BONE. ONCE IT REACHED THE CORTICAL BONE, THE ANCHOR BODY SPLIT IN HALF AROUND THE SELF-PUNCHING EYELET. THE AR-2325PSLC PEEK SWIVELOCK WAS USED TO FILL THE BONE SOCKET THE AR-1926BCSP BIOCOMPOSITE PUSHLOCK CREATED. HOWEVER, THE ANCHOR PULLED OUT OF THE BONE. A 4.75 MM SWIVELOCK WAS USED TO COMPLETE THE REPAIR. THIS WAS DISCOVERED DURING A CUFFMEND PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 7/2/2024: THE SURGERY WAS PERFORMED ON (B)(6) 2024. ALL BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING AN AR-2324PSP PEEK SWIVELOCK.

  Patient problems: Insufficient Information

  MAUDE report 19817416 ↗
• MalfunctionMay 21, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE SURGEON WAS PLACING THE AR-2325PSLC, THE PEEK WOULD NOT SEAT. THE DEVICE WAS REMOVED AND THE CASE WAS COMPLETED BY USING ANOTHER WITHOUT FURTHER ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19359269 ↗
• MalfunctionApr 29, 2024Defective Device; Defective Device

  ON 11/23/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2325PSLC PEEK SWIVELOCK ANCHOR BODY DEFORMED DURING INSERTION, DESPITE DRILLING AND TAPPING. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200566 ↗
• MalfunctionApr 29, 2024Break; Break

  ON (B)(6) 2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2325PSLC PEEK SWIVELOCK COULD NOT BE INSERTED. THIS WAS DISCOVERED DURING A MPFL RECONSTRUCTION ON (B)(6) 2021, AFTER SURGEON DRILLED THE SIDE OF PATELLA WITH A 2.4MM K-WIRE, THE SUTURE ANCHOR COULD NOT BE INSERTED. SURGEON RELOADED SWIVELOCK BUT THE SAME ISSUE OCCURRED. CASE WAS COMPLETED BY USING A NEW DEVICE; PATIENT WAS NOT AFFECTED. ADDITIONAL INFORMATION RECEIVED 10/7/2021 SWIVELOCK SUTURE ANCHOR BROKE BEFORE IT COULD BE INSERTED AND NO BROKEN FRAGMENTS HAD TO BE RETRIEVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200433 ↗
• MalfunctionApr 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANKLE INTERNAL BRACE PROCEDURE, THE AR-2325PSLC AND THE AR-8990, PULLED OUT DUE TO THE BONE QUALITY AND LOCATION. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19171849 ↗
• MalfunctionFeb 21, 2024Break; Break

  ON 1/30/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-2325PSLC SUTURE ANCHOR BROKE DURING INSERTION. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE CASE WAS DELAYED 40 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE WAS COMPLETED USING ANOTHER NEW AR-2325PSLC SUTURE ANCHOR WITH NO SECONDARY PROCEDURE NEEDED. THIS WAS DISCOVERED DURING AN INTERNALBRATH ANKLE JOINT ARTHROSCOPY PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18747687 ↗
• MalfunctionOct 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 9/26/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-2325PSLC PEEK SWIVELOCK ANCHOR PULLED OUT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18003328 ↗
• MalfunctionSep 27, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-2325PSLC PEEK SWIVELOCK ANCHOR BROKE DURING INSERTION AND PULLED THE SUTURE. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. ALL THE BROKEN FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED USING ANOTHER AR-2325PSLC PEEK SWIVELOCK. ADDITIONAL INFORMATION RECEIVED ON 9/12/2023: THE CASE WAS DELAYED TEN MINUTES.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17827404 ↗
• MalfunctionMay 11, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2325PSLC PEEK SWIVELOCK ANCHOR BROKE DURING INSERTION. ALL FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED USING ANOTHER AR-2325PSLC PEEK SWIVELOCK ANCHOR. THIS WAS DISCOVERED DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913501 ↗
• MalfunctionSep 26, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2325PSLC SUTURE ANCHOR BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT SPACE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 15484168 ↗
• MalfunctionMay 9, 2022Break

  IT WAS REPORTED ON 04/26/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-2325PSLC SUTURE ANCHOR BROKE WHEN SCREWED IN. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT. PER FACILITY: "THE NAIL WAS FOUND TO BE BROKEN WHEN IT WAS SCREWED DURING THE PROCEDURE (SEE ATTACHED PICTURE). NO FRAGMENT LEFT INSIDE THE PATIENT. THE SURGEN USED ANOTHER PRODCUT WITH SAME TYPE AND LOT TO COMPLETE THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337246 ↗
• MalfunctionDec 13, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2325PSLC SWIVELOCK BROKE WHEN BEING IMPLANTED. THIS WAS DISCOVERED DURING ANKLE LIGAMENT REPAIR AND INTERNAL FIXATION PROCEDURE ON (B)(6) 2021. WHEN SURGEON USED A HAMMER TO INSERT THE PEEK IMPLANT, IT BROKE INSIDE THE PATIENT. SURGEON USED A NEW SWIVELOCK DEVICE FROM A DIFFERENT LOT NUMBER TO COMPLETE PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 12983920 ↗