Arthrex® AR-2323PSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867384491), received between Apr 22, 2024 and Jan 5, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2323PSP SELF-PUNCHING PEEK SWIVELOCK TIP BROKE WITH LIGHT MALLETING TAPS. THE CASE WAS COMPLETED USING TWO ADDITIONAL AR-2323PSP SELF-PUNCHING PEEK SWIVELOCKS. ALL BROKEN FRAGMENTS WERE REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS ISSUE WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 19-DEC-2025: THE ANCHOR WAS REMOVED FROM THE PATIENT, AND THE REPAIR WAS COMPLETED USING ADDITIONAL AR-2323PSP SELF-PUNCHING PEEK SWIVELOCK ANCHORS. THE CASE WAS DELAYED BY APPROXIMATELY 8¿10 MINUTES, RESULTING IN AN ESTIMATED 8¿10 MINUTES OF ADDITIONAL ANESTHESIA TIME.

  Patient problems: Insufficient Information

  MAUDE report 23961056 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A SUBSCAPULARIS TENDON RUPTURE SURGERY THE TIP OF THE SCREW BROKE DURING PUNCHING INTO THE BONE. ALL PARTS WERE RETRIEVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE WITH THE PART NUMBER AR-2324BCC. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873178 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A SPEEDFIX SHOULDER SURGERY THE TIP OF THE SCREW BROKE DURING PUNCHING INTO THE BONE. ALL PARTS WERE RETRIEVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE WITH THE PART NUMBER AR-2324BCC. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873167 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A SPEEDFIX SHOULDER SURGERY THE TIP OF THE SCREW BROKE DURING PUNCHING INTO THE BONE. ALL PARTS WERE RETRIEVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE WITH THE PART NUMBER AR-2324BCC. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873165 ↗
• MalfunctionFeb 19, 2025Break; Break

  ON 2/4/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE TIP EYELET ON THREE AR-2323PSP SELF-PUNCHING PEEK SWIVELOCK WERE NOT PROPERLY SET ON THE DRIVERS, AND THEY BROKE DURING INSERTION. IT SEEMED LIKE THERE WAS SLACK IN THE SLIDING SUTURE CAUSING THE EYELID TO FLIP SIDEWAYS WHEN PUNCHING IN. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 2/7/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409531 ↗
• MalfunctionFeb 19, 2025Break; Break

  ON 2/4/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE TIP EYELET ON THREE AR-2323PSP SELF-PUNCHING PEEK SWIVELOCK WERE NOT PROPERLY SET ON THE DRIVERS, AND THEY BROKE DURING INSERTION. IT SEEMED LIKE THERE WAS SLACK IN THE SLIDING SUTURE CAUSING THE EYELID TO FLIP SIDEWAYS WHEN PUNCHING IN. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2025. ADDITIONAL INFORMATION REQUESTED ON 2/7/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409521 ↗
• MalfunctionFeb 18, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE TIP EYELET ON THREE AR-2323PSP SELF-PUNCHING PEEK SWIVELOCK WERE NOT PROPERLY SET ON THE DRIVERS, AND THEY BROKE DURING INSERTION. IT SEEMED LIKE THERE WAS SLACK IN THE SLIDING SUTURE CAUSING THE EYELID TO FLIP SIDEWAYS WHEN PUNCHING IN. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 2/7/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399121 ↗
• MalfunctionJun 6, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE EYELET FROM AN AR-2323PSP SELF PUNCHING PEEK SWIVELOCK BROKE DURING INSERTION. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 5/17/2024: THE CASE WAS COMPLETED BY REMOVING ALL THE BROKEN FRAGMENTS AND USING A NEW AR-2323PSP SELF-PUNCHING PEEK SWIVELOCK. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 19478349 ↗
• MalfunctionApr 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2323PSP PEEK SWIVELOCK TIP KEPT FALLING AND BENDING OFF THE SHAFT. THE SUTURETAPE IS BELIEVED TO BE INFERIOR COMPARED TO THE NUMBER TWO FIBERWIRE AS A HOLDING MECHANISM FOR THE EYELET AND SELF-PUNCHING TIP. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 3/28/2024: THE TIP DID NOT BREAK OFF OR WAS LOOSE IN THE PATIENT. THE CASE WAS COMPLETED USING AN AR-2323PSLM PEEK SWIVELOCK SP. THE CASE WAS DELAYED FIVE MINUTES WITHOUT ADDITIONAL ANESTHESIA. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153007 ↗