Arthrex® AR-2324PSLC-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00888867098145), received between Jun 1, 2021 and Jul 31, 2026 — classified as 1 injury, 41 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100192 ↗
• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT DURING THE ARTHROSCOPY, THE ANCHOR BROKE DURING INSERTION. 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. UPDATE 11-MAR-2026 - FURTHER INFORMATION WAS RECEIVED: NO FRAGMENTS REMAIN IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629324 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE PIN OF THE DEVICE BROKE OFF DURING INSERTION OF THE DEVICE INTO THE TIBIAL BONE. 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 BY APPLICATION OF A DIFFERENT FIBERTAPE MOUNTING. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413508 ↗
• MalfunctionFeb 19, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE SURGERY ON THE ANTERIOR TALOFIBULAR LIGAMENT, THE ANCHOR WAS PULLED OUT WHEN PERFORMING A STRENGTH TEST. BEFORE THE ANCHOR WAS INSERTED, A HOLE WAS DRILLED AND THREADS WERE CUT INTO THE BONE. 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. THE NEW ANCHOR WAS INSERTED INTO THE SAME HOLE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388126 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE BROKE DURING IMPLANTATION. ALL PARTS WERE RETRIEVED. 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 23956765 ↗
• MalfunctionDec 8, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY DESPITE A PROPER BONE PREPARATION THE IMPLANT COULD NOT BE FIXATED. 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 23744740 ↗
• MalfunctionDec 8, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, IT WAS NOTICED THAT NO SUTURES WERE ATTACHED TO THE ANCHOR. 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. ADDITIONAL INFORMATION WAS RECEIVED FROM ARTHREX PL: IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY, WHEN THE DEVICE WAS INSERTED INTO THE JOINT, IT WAS NOTICED THAT NO SUTURES WERE ATTACHED TO THE ANCHOR. 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 23742300 ↗
• MalfunctionDec 3, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE IMPLANT WAS ATTACHED TO THE HEAD OF THE HUMERUS AS THE SECOND ROW IN THE SPEEDBRIDGE, UNFORTUNATELY, THE IMPLANT CAME LOOSE AT THE FINAL STAGE AFTER THE SUTURE WAS CUT. 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 23707334 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE EYELET BROKE WHILE THE ANCHOR WAS INSERTED INTO THE BONE. 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 23475848 ↗
• MalfunctionSep 12, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE IMPLANT DID NOT ANCHOR. 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 23043381 ↗
• MalfunctionSep 3, 2025Material Twisted/Bent; Damaged Thread; Material Twisted/Bent; Damaged Thread

  ON 14TH AUGUST 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1588BTB, BTB TIGHTROPE®, AFTER AR-1588RT-IB BROKE ((B)(4)), AR-1588BTB WAS OPENED TO BE USED AS A NEW FEMORAL TIGHTROPE. WHEN CINCHING THE GRAFT INTO THE FEMORAL SOCKET, THE BTB TIGHTROPE BROKE. IT WAS ALSO REPORTED THAT FOR AN AR-2324PSLC, SUTURE ANCHOR, PEEK-SWIVELOCK® C, 4.75 X 19.1 MM, VENTED, WHEN ATTEMPTING TO SECURE THE INTERNAL BRACE TO THE SHIN, THE ANCHOR THREADS BROKE/BENT UPON INSERTION. THE DOCTOR DRILLED 4.5MM INTO THE MEDIAL TIBIA AND USED 4.75 SWIVELOCK TAP. THIS WAS DETECTED DURING USE IN A ACL GRAFTLINK PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A 2ND AR-1588RT-IB TIGHTROPE WAS OPENED AND USED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 22950927 ↗
• MalfunctionSep 2, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED DURING THE MENISCAL ROOT REPAIR SURGERY THAT THE ANCHOR WOULD NOT SEAT IN THE BONE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH AN AR-1588TB-3. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22941794 ↗
• MalfunctionAug 15, 2025Positioning Failure; Failure to Advance; Positioning Failure; Failure to Advance

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE IMPLANT DID NOT ANCHOR. 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 22815331 ↗
• MalfunctionAug 13, 2025Crack; Crack

  IT WAS REPORTED DURING THE ARTHROSCOPIC THAT THE IMPLANT IS CRACKED. 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. ADDITIONAL INFORMATION, 31-JULY-2025: FURTHER INFORMATION WERE RECEIVED THAT ALL BROKEN PARTS OF THE IMPLANT WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793145 ↗
• MalfunctionAug 13, 2025Crack; Crack

  IT WAS REPORTED DURING THE ARTHROSCOPIC THAT THE IMPLANT IS CRACKED. 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. ADDITIONAL INFORMATION, 31-JULY-2025: FURTHER INFORMATION WERE RECEIVED THAT ALL BROKEN PARTS OF THE IMPLANT WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793107 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE IMPLANT RUPTURED WHEN INSERTING THE DEVICE. 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 22535531 ↗
• MalfunctionJun 18, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 27TH MAY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-2324PSLC-1 SUTURE ANCHOR, PEEK-SWIVELOCK® C, 4.75 X 19.1 MM, VENTED, THE PEEK EYELET FROM SWIVELOCK WAS BENT PRIOR TO INSERTION AND WAS UNABLE TO RETAIN SUTURE. THEY USED A DRILL AND TAP ON THE TIBIA FOR BACKING UP SUTURES FROM ACL GRAFT. THIS WAS DETECTED DURING USE IN AN ACL RECONSTRUCTION ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY UTILIZED ANOTHER SWIVELOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282632 ↗
• MalfunctionJun 16, 2025Break; Break

  ON 23RD MAY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-2324PSLC-1, SUTURE ANCHOR, PEEK-SWIVELOCK® C, 4.75 X 19.1 MM, VENTED, THE SWIVELOCK SCREW SNAPPED ON INSERTION. THEY WERE ABLE TO GET THE EYELET OUT, NO ONE WAS HARMED AND THE ANCHOR WAS COMPLETELY REMOVED. THIS WAS DETECTED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2025. PROCEDURE WAS COMPLETED WITH NO ISSUES. 26TH MAY 2025, THE ARTHREX EMPLOYEE REPLIED THAT THIS WAS DETECTED DURING AN ACL QUADLINK WITH INTERNAL BRACE, DOCKED USING SWIVELOCK PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED BY USING A 3.5 DRILL FROM INTERNAL BRACE KIT INTO THE TIBIA, 1CM BELOW THE TIBIAL TUNNEL USED FOR ACL GRAFT. 3.5M DRILL FOLLOWED BY THE 4.75MM TAP ALSO IN INTERNAL BRACE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214299 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE ANCHOR DISINTEGRATED DURING IMPLANTATION. 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. UPDATE (B)(6) 12-MAY-2025. FURTHER INFORMATION WAS RECEIVED THAT THE IMPLANT BROKE DURING INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045834 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE DEVICE BROKE. 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 21919180 ↗
• MalfunctionMar 17, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE DEVICE BROKE WHILE SCREWING. 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 21620299 ↗
• InjuryJun 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01 MAY 2024 IT WAS REPORTED BY A PRODUCT SURVEILLANCE SPECIALIST IN ARTHREX INC THAT THEY HAD RECEIVED A REPORT OF A POTENTIAL ADVERSE EVENT THAT OCCURRED DURING A CLINICAL STUDY IN THE UNIVERSITY OF WESTERN AUSTRALIA. THE ARTHREX PRODUCTS THAT WERE INVOLVED WERE: AR-1588R-IB ACL REPAIR TIGHTROPE, WITH INTERNALBRACE, AR-2324PSLC-1 PEEK SWIVELOCK C,4.75X19.1MM & AR-7282-25-1 FIBERRING WITH SHUTTLE SUTURE25MM,SINGLE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED POST-OPERATIVE PARTIAL OCCLUSION OF PERONEAL VEIN, TREATED WITH ELIQUIS WITH FULL RECOVERY AND WITHOUT FURTHER SEQUALAE. MORE INFORMATION TO BE CONFIRMED. THERE WAS CASE INVOLVEMENT.

  Patient problems: Failure of Implant

  MAUDE report 19562865 ↗
• MalfunctionJun 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01 MAY 2024 IT WAS REPORTED BY A PRODUCT SURVEILLANCE SPECIALIST IN ARTHREX INC THAT THEY HAD RECEIVED A REPORT OF A POTENTIAL ADVERSE EVENT THAT OCCURRED DURING A CLINICAL STUDY IN THE UNIVERSITY OF WESTERN AUSTRALIA. THE ARTHREX PRODUCTS THAT WERE INVOLVED WERE: AR-1588R-IB ACL REPAIR TIGHTROPE, WITH INTERNALBRACE, AR-2324PSLC-1 PEEK SWIVELOCK C,4.75X19.1MM & AR-7282-25-1 FIBERRING WITH SHUTTLE SUTURE25MM,SINGLE. IT WAS REPORTED THAT THE PATIENT THAT UNDERWENT AN ACL REPAIR HAS HAD A LATERAL EXTRA-ARTICULAR TENODESIS ON THE SAME LEG AT 8 MONTHS POST- ACL REPAIR SURGERY. THERE WAS CASE INVOLVEMENT.

  Patient problems: Failure of Implant

  MAUDE report 19480412 ↗
• MalfunctionMay 9, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE IMPLANT COULD NOT BE ANCHORED. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 19278189 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE ANCHOR OF THE DEVICE BROKE WHEN PUTTING THE SUTURE THROUGH THE EYELET. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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. UPDATE AVOE 14-NOV-2022 IT WAS CONFIRMED THAT THE DEVICE DIDN`T BREAK INSIDE THE PATIENT AND NOTHING HAD TO BE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19135283 ↗