Arthrex® AR-2323PSLC-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867097964), received between Aug 8, 2023 and Sep 11, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734399 ↗
• MalfunctionJul 30, 2026Crack

  Patient problems: Insufficient Information

  MAUDE report 50082405 ↗
• MalfunctionNov 17, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE ANCHOR COULD NOT BE SCREWED INTO 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 23567759 ↗
• MalfunctionOct 20, 2025Break; Break

  ON 12TH OCTOBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-2323PSLC-1, SUTURE ANCHOR, PEEK SWIVELOCK® C, 5.5 MM X 19.1 MM, CLOSED EYELET, WHEN SUTURES WERE BEING LOADED INTO A 5.5MM SWIVELOCK ANCHOR, THE RETENTION SUTURE HOLDING THE PEEK EYELET BROKE MEANING THE EYELET COULD NO LONGER STAY ATTACHED TO THE ANCHOR BY WAY OF RETENTION SUTURE. THIS WAS DETECTED DURING USE IN AN ACL REPAIR ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW SWIVELOCK WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 23334862 ↗
• MalfunctionFeb 7, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE EYLETE AND SUTURE OF 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. ***UPDATE AVOE 04-FEB-2025 IT WAS CONFIRMED THAT THE EYELET OF THE DEVICE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333252 ↗
• MalfunctionApr 24, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE ANCHOR OF THE DEVICE CRACKED AND WAS STILL CONNECTED TO THE DRIVER. THE DEVICE WAS DAMAGED OUTSIDE OF THE PATIENT. 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 19171394 ↗
• MalfunctionAug 8, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE IMPLANT WAS LOOSE AFTER TIGHTENING, IT DID NOT HOLD IN THE BONE. 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 17480048 ↗