Arthrex® AR-2324PSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00888867384576), received between Oct 24, 2023 and Sep 24, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885281 ↗
• MalfunctionSep 10, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50717572 ↗
• MalfunctionSep 10, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50717116 ↗
• MalfunctionJul 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50053901 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE TIPS OF THREE DEVICES AR-2324PSP (LOT: 15375183) BENT AND BROKE OFF. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. 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 24413230 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE TIPS OF THREE DEVICES AR-2324PSP (LOT: 15375183) BENT AND BROKE OFF. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. 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 24413159 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE TIPS OF THREE DEVICES AR-2324PSP (LOT: 15375183) BENT AND BROKE OFF. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. 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 24413104 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE TIP OF THE DEVICE BROKE DURING INSERTION. ALL PARTS WERE RETRIEVED FROM THE PATIENT. 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 23451108 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE TIP OF THE DEVICE BROKE DURING INSERTION. ALL PARTS WERE RETRIEVED FROM THE PATIENT. 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 23451079 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE TIP OF THE DEVICE BROKE DURING INSERTION. ALL PARTS WERE RETRIEVED FROM THE PATIENT. 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 23450818 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SUTURE SURGERY THE TIP OF THE DEVICE BROKE OFF. 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: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664647 ↗
• MalfunctionMar 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE PEEK SP SWIVELOCK 4.75 TIP BROKE IN THE PATIENT. THIS HAPPEND TWICE WITH TWO DIFFERENT PEEK SP SWIVELOCKS 4.75MM. THE BROKEN OFF PIECES HAVE 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-2324PSLM. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653354 ↗
• MalfunctionMar 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE PEEK SP SWIVELOCK 4.75 TIP BROKE IN THE PATIENT. THIS HAPPEND TWICE WITH TWO DIFFERENT PEEK SP SWIVELOCKS 4.75MM. THE BROKEN OFF PIECES HAVE 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-2324PSLM. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653304 ↗
• MalfunctionFeb 21, 2025Break; Break

  ON 02/07/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2324PSP SWIVELLOCK EYELET BROKE OFF WHILE TRYING TO INSERT IT INTO THE HUMORAL HEAD. THEY WERE ABLE TO REMOVE THE IMPLANTS AND THE BROKEN EYELET AND REPLACED THEM WITH THE SAME PART NUMBERS SUCCESSFULLY. THE PATIENT WAS NOT HARMED AND THE PROCEDURE WAS ABLE TO CONTINUE AND BE COMPLETED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432578 ↗
• MalfunctionJan 23, 2025Manufacturing, Packaging or Shipping Problem; Material Deformation; Manufacturing, Packaging or Shipping Problem; Material Deformation

  ON 12/30/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-2324PSP PEEK SWIVELOCK SP HAD A DEFORMED EYELET ON THE 4.75MM SELF-PUNCHING SWIVELOCK RIGHT OUT OF THE PACKAGE. THE SURGEON TRIED TO USE IT STILL IN THE PATIENT'S SHOULDER, BUT IT WAS IMPOSSIBLE TO USE AS A SELF-PUNCHING ANCHOR OR EVEN AFTER A HOLE HAD BEEN PRE-PUNCHED. THE ANCHOR WAS DISCARDED, AND A NEW ANCHOR WAS OPENED TO COMPLETE THE CASE. THIS WAS DISCOVERED WHEN OPENING THE PACKAGE DURING A PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218078 ↗
• MalfunctionOct 31, 2024Break; Break

  ON 10/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324PSP SELF PUNCHING PEEK SWIVELOCK ANCHOR BROKE DURING INSERTION. THE SURGEON PLACED THE ANCHOR ON THE BONE AND WENT TO LIGHTLY MALLET IN THE ANCHOR WHEN IT IMMEDIATELY SNAPPED THE TIP IN HALF. EVERYTHING WAS REMOVED FROM THE PATIENT. THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6)2024. ADDITIONAL INFORMATION RECEIVED ON 10/24/2024: THE CASE WAS DELAYED IN RETRIEVING THE BROKEN TIP; ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 20579117 ↗
• MalfunctionSep 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON(B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-2324PSP PEEK SWIVELOCK SP HAD ISSUES. THE FIRST PEEK SWIVELOCK SP WAS INSERTED PROPERLY. ONCE THE ANCHOR BODY WAS DOWN TO BONE, THE SURGEON ADVANCED THE ANCHOR. EVERY TIME THE INSERTER WAS ROTATED IT PULLED ON THE SUTURES COMING OFF THE MEDIAL ROW OF THE FIBERTAK ANCHOR. IT APPEARED AS IF THE EYELET WAS ROTATING WITH THE INSERTER AS IT WAS TURNED CLOCKWISE. WHEN REMOVING THE PEEK SWIVELOCK SP, THE EYELET WOULD NOT COME OUT. THE EYELET WAS UNABLE TO BE REMOVED BUT EVERYTHING ELSE WAS. ON THE SECOND LATERAL ROW OF THE PEEK SWIVELOCK SP, THE SURGEON USED THE GREEN PUNCH DOWN TO THE SECOND LASER LINE TO CREATE A PILOT HOLE. THE SAME ISSUE OCCURRED WITH THE SECOND SWIVELOCK AS IT DID WITH THE FIRST. THE EYELET AND THE REST OF THE SECOND SWIVELOCK WERE REMOVED WITHOUT ISSUES. THE FIBERTAK REMAINED IN THE PATIENT. THE CASE WAS COMPLETED BY USING TWO AR-2324PSLC PEEK SWIVELOCK C FOR THE LATERAL ROW. THE PATIENT CONSTRUCT WAS COMPLETED AS NORMAL, AND THERE WERE NO ADVERSE EVENTS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2024. THE CASE WAS NOT DELAYED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20169707 ↗
• MalfunctionSep 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 8/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-2324PSP PEEK SWIVELOCK SP HAD ISSUES. THE FIRST PEEK SWIVELOCK SP WAS INSERTED PROPERLY. ONCE THE ANCHOR BODY WAS DOWN TO BONE, THE SURGEON ADVANCED THE ANCHOR. EVERY TIME THE INSERTER WAS ROTATED IT PULLED ON THE SUTURES COMING OFF THE MEDIAL ROW OF THE FIBERTAK ANCHOR. IT APPEARED AS IF THE EYELET WAS ROTATING WITH THE INSERTER AS IT WAS TURNED CLOCKWISE. WHEN REMOVING THE PEEK SWIVELOCK SP, THE EYELET WOULD NOT COME OUT. THE EYELET WAS UNABLE TO BE REMOVED BUT EVERYTHING ELSE WAS. ON THE SECOND LATERAL ROW OF THE PEEK SWIVELOCK SP, THE SURGEON USED THE GREEN PUNCH DOWN TO THE SECOND LASER LINE TO CREATE A PILOT HOLE. THE SAME ISSUE OCCURRED WITH THE SECOND SWIVELOCK AS IT DID WITH THE FIRST. THE EYELET AND THE REST OF THE SECOND SWIVELOCK WERE REMOVED WITHOUT ISSUES. THE FIBERTAK REMAINED IN THE PATIENT. THE CASE WAS COMPLETED BY USING TWO AR-2324PSLC PEEK SWIVELOCK C FOR THE LATERAL ROW. THE PATIENT CONSTRUCT WAS COMPLETED AS NORMAL, AND THERE WERE NO ADVERSE EVENTS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. THE CASE WAS NOT DELAYED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20169691 ↗
• MalfunctionJun 17, 2024Break; Break

  ON 5/31/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324PSP SWIVELOCK EYELET BROKE DURING INSERTION. ALL THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS COMPLETED USING A PRODUCT FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024.

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

  MAUDE report 19547325 ↗
• MalfunctionOct 24, 2023Unintended Movement; Unintended Movement

  ON 9/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE SUTURES FROM AN AR-2324PSP PEEK SWIVELOCK CONTINUED TO ROTATE WITH THE ANCHOR. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. PROCEDURE WAS COMPLETED BY USING TWO PEEK SWIVELOCK ANCHORS. THE ONE EYELET FROM AR-2324PSP WOULD NOT COME OUT WITHOUT DESTROYING THE SURROUNDING BONE. SMALL DELAY TROUBLESHOOTING THE ISSUE AND REMOVING THE FAILED ITEMS. NOTHING SIGNIFICANT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17997207 ↗