Arthrex® AR-2323PSLCRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888867026797), received between Jul 21, 2017 and Apr 20, 2026 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Positioning Failure

  ON 01-APR-2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA PHONE THAT AN AR-2323PSLC SUTURE ANCHOR, PEEK SWIVELOCK'S ANCHORS THREADS DID NOT ENGAGE PROPERLY, THEY DETERIORATED UPON INSERTION INTO THE ANTERIOR TIBIA WHILE IN USE WITH #2 FIBERWIRE. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION USING HAMSTRING AUTOGRAFT TENDON WITH INTERNAL BRACE WITH NO PATIENT HARM REPORTED. THE CASE WAS COMPLETED WITH ANOTHER AR-2323PSLC OF THE SAME LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931072 ↗
• MalfunctionNov 21, 2025Break; Break

  ON 11/03/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-2323PSLC PEEK SWIVELOCK SUTURE ANCHOR TIP BROKE AFTER PLACEMENT DURING A SHOULDER ARTHROSCOPY. ANOTHER ANCHOR WAS OPENED WITH AUTHORIZATION. THE PATIENT HAD GOOD BONE QUALITY, AND ALL FRAGMENTS WERE REMOVED. THERE WAS NO DELAY IN THE PROCEDURE, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619823 ↗
• MalfunctionSep 19, 2025Defective Device; Defective Device

  ON 09/01/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-1928SF-2 AND AN AR-2323PSLC SUTURE ANCHOR EXPERIENCED ANCHOR FAILURE DURING USE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23095182 ↗
• MalfunctionAug 13, 2025Break; Crack; Break; Crack

  ON (B)(6) 2025, A FACILITY REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2323PSLC PEEK SWIVELOCK ANCHOR FAILED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2025. WHILE INSERTING THE ANCHOR, A CRACKING SOUND WAS HEARD. THE ANCHOR WAS REMOVED, AND NO HARM OCCURRED TO THE PATIENT. A REPLACEMENT ANCHOR WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED ON 08/04/2025: AN AR-2323PSLC PEEK SWIVELOCK ANCHOR WAS USED TO COMPLETE THE CASE. NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED. THE AR-2323PSLC WAS USED TO PREPARE THE BONE SOCKET FOR IMPLANT INSERTION. THE BONE QUALITY OF THE PATIENT WAS ASSESSED AS HARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792828 ↗
• MalfunctionMay 23, 2025Defective Device; Damaged Thread; Defective Device; Damaged Thread

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE THREAD OF THE DEVICE WAS DEFECTIVE. 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 AVOE (B)(6) 2025 IT WAS CONFIRMED THAT THE IMPLANT COULDN`T BE INSERTED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079626 ↗
• MalfunctionApr 24, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THE AR-2323PSLC, PEEK SWIVELOCK ANCHOR, WOULD NOT ADVANCE INTO DRILLED HOLE/STARTED FRAYING SUTURES. ADDITIONAL INFORMATION 6/15/2021: IT WAS REPORTED DURING SHOULDER SCOPE AND ROTATOR CUFF REPAIR THE AR-2323PSLC, PEEK SWIVELOCK ANCHOR, WOULD NOT ADVANCE INTO DRILLED HOLE/STARTED FRAYING SUTURES. THE CASE WAS COMPLETED USING AN ADDITIONAL 5.5 SWIVELOCK ANCHOR.

  Patient problems: Insufficient Information

  MAUDE report 19172031 ↗
• MalfunctionOct 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 9/26/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AR-2323PSLC PEEK SWIVELOCK C ANCHOR PULLED OUT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18003455 ↗
• MalfunctionDec 27, 2022Break

  ON 12/8/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2323PSLC PEEK SWIVELOCK FAILED. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETE WITH ANOTHER AR-2323PSLC PEEK SWIVELOCK. ADDITIONAL INFORMATION RECEIVED ON 12/16/2022: THE AR-2323PSLC PEEK SWIVELOCK EYELET BROKE OFF INSIDE THE PATIENT DURING INSERTION BUT RIGHT BEFORE IT WAS IMPLANTED IN BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16052041 ↗
• MalfunctionJul 27, 2021Material Fragmentation

  IT WAS REPORTED THAT THE AR-2323PSLC, WAS DAMAGED WHEN THE IMPLANT WAS INSERTED. USED A NEW PRODUCT AND THE CASE IS COMPLETED. NO ADVERSE EFFECT ON THE PATIENT. ADDITIONAL INFORMATION PROVIDED 7/8/21: PROCEDURE BEING PERFORMED WAS AN ARCR. THE SEATED DEPTH OF IMPLANT WAS ABOUT HALF. THE BONE QUALITY OF THE PATIENT WAS HARD. ALL BROKEN FRAGMENTS WERE COLLECTED AND RETRIEVED. THE CASE WAS COMPLETED BY USING A NEW AR-2323PSLC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231654 ↗
• MalfunctionMar 22, 2021Break

  IT WAS REPORTED THAT THE AR-2323PSLC, ANCHOR BROKE WHEN INSERTED INTO THE HOLE IN THE BONE. THE SURGEON REMOVED THE BROKEN PIECES WITH NO PROBLEM. NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11547730 ↗
• MalfunctionFeb 1, 2021Loose or Intermittent Connection; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER AN INITIAL SURGERY THE ANCHOR BECAME LOOSE AND MIGRATED OUT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. DURING THE REVISION SURGERY THE TENDON WAS FIXATED WITH A NEW CORKSCREW ANCHOR. NO FURTHER INFORMATION RECEIVED.

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

  MAUDE report 11259287 ↗
• InjuryJun 16, 2020Break

  IT WAS REPORTED THAT THE PEEK SWIVELOCK, AR-2323PSLC, WAS BEING USED IN A ROTATOR CUFF SURGERY. THE ANCHOR BROKE DURING INSERTION INTO THE BONE, AND THE BROKEN PIECES FELL INTO THE PATIENT¿S BODY. THE SURGEON RETRIEVED THE BROKEN PIECES USING FORCEPS, BUT COULD NOT RETRIEVE ALL THE BROKEN PIECES. THE SURGERY WAS COMPLETED USING A NEW PRODUCT OF THE SAME PART NUMBER. THE BONE QUALITY OF THE PATIENT WAS HARD. NO X-RAY TAKEN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10157848 ↗
• InjuryDec 20, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR RIGHT SHOULDER PROCEDURE, THE TIP OF THE AR-2323PSLC SUTURE ANCHOR PEEK SWIVELOCK BROKE OFF IN THE BONE. DECISION WAS MADE BY SURGEON TO LEAVE THE BROKEN TIP IN THE PATIENT. THE REMAINING PARTS OF THE ANCHOR WERE SENT TO THE FACILITY'S RISK MANAGEMENT. THE FACILITY REPORTED THE REMAINING PORTIONS ARE AVAILABLE TO RETURN FOR EVALUATION. THE ORIGINAL INTENDED PROCEDURE WAS AS FOLLOWS; ARTHROSCOPIC ROTATOR CUFF REPAIR RIGHT SHOULDER. ARTHROSCOPIC EXTENSIVE DEBRIDEMENT OF THE GLENOHUMERAL JOINT INCLUDING ARTICULAR. CARTILAGE, LABRUM, PARA-LABRAL CYST, SUBACROMIAL SCARRING AND ADHESIONS, INTRA-ARTICULAR BICEPS TENDON. OPEN EXCISIONAL BIOPSY LATERAL SOFT TISSUE LESION RIGHT SHOULDER.

  Patient problems: Foreign Body In Patient

  MAUDE report 9506179 ↗
• MalfunctionDec 16, 2019Break

  TIP OF SHOULDER ANCHOR BROKE OFF IN THE BONE. REMAINING PARTS OF ANCHOR WILL BE SENT TO RISK MANAGEMENT. THE TIP OF ANCHOR REMAINED IN SHOULDER. DECISION WAS MADE TO KEEP TIP IN BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9472988 ↗
• InjuryApr 18, 2019Device Slipped

  IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2018 AND IS PART OF A SHOULDER ARTHROSCOPY STUDY. THE 2018 PROCEDURE WAS PERFORMED IN (B)(6). NOW PATIENT¿S ANCHOR IS LOOSE AND A REVISION SURGERY IS SCHEDULED FOR (B)(6) 2019, IN (B)(6) TO REMOVE THE ANCHOR. THE ANCHOR PART NUMBER IS AR-2323PSLC, LOT UNKNOWN. UPDATE 01-APR-2019: THE REVISION SURGERY ON (B)(6) 2019 TOOK PLACE AND WENT WELL. THE ANCHOR WILL NOT BE RETURNED BECAUSE IT REMAINS IN THE PATIENT. IT TURNED OUT THAT THE PATIENT HAD AN ABNORMAL REACTION TO THE SUTURES WHICH RESULTED IN EXCESSIVE SCAR TISSUE BEING FORMED. SURGEON ONLY REMOVED THE SUTURES, THE ANCHOR REMAINS IN PLACE. UPDATE 02-APR-2019: THE SCAN WAS TAKEN BEFORE THE REVISION, IT SUGGESTED THAT THE ANCHOR CAME LOOSE. BUT DURING THE REVISION SURGERY THE SURGEON DIDN´T SEE THE ANCHOR. IT WAS COVERED BY SCAR TISSUE, WHICH PROBABLY GAVE A FALSE IMAGE ON THE SCAN. SURGEON DECIDED NOT TO SEARCH FOR THE ANCHOR BECAUSE HE DIDN´T WANT TO CAUSE MORE DAMAGE TO THE CUFF.

  Patient problems: Reaction; Scar Tissue

  MAUDE report 8526608 ↗
• InjuryJul 21, 2017Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT PATIENT HAD UNDERGONE ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2017. POST SURGERY THE PATIENT BECAME TENDER WITH PAIN ON TOUCH AT THE SHOULDER AND APPROXIMATELY 4 WEEKS POST SURGERY IT WAS NOTICED THE INCISION FELT MOIST. SURGEON DREW FLUID FROM THE INCISION SITE AND CULTURE CAME BACK NEGATIVE. PATIENT WAS PUT ON ANTIBIOTICS AS A PRECAUTION. THE INCISION SITE BECAME SWOLLEN AND RED AND HAD TO BE DRAINED. AT THAT TIME PUS WAS FOUND AND PATIENT WAS KEPT ON ANTIBIOTICS. THE INCISION SITE CONTINUE TO SHOW DRAINAGE AND CULTURES CONTINUED TO COME BACK NEGATIVE. ON (B)(6)2017 SURGEON PERFORMED A SECOND SURGERY TO REMOVE ALL IMPLANTS FROM THE (B)(6) 2017 PROCEDURE. SURGEON INFORMED PATIENT THAT WHEN HE MOVED UNDER THE DELTOID HE FOUND SIGNIFICANT PUS AND FOUND THAT SOME OF THE ROTATOR CUFF MUSCLE HAD BEEN EATEN AWAY (PATIENT'S WIFE'S DESCRIPTION). CULTURE WAS AGAIN NEGATIVE. PATIENT WAS PUT ON IV ANTIBIOTICS FOR 4 WEEKS. ADDITIONAL INFORMATION OBTAINED (B)(6) 2017 FROM PATIENT BILLING RECORDS: PATIENT'S IMPLANTS WERE FOUR AR-2323PSLC, PEEK SWIVELOCK C SUTURE ANCHORS.

  Patient problems: Erythema; Pain; Purulent Discharge; Swelling; Tissue Damage

  MAUDE report 6731368 ↗