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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867098152), received between Feb 11, 2020 and Nov 5, 2024 — classified as 1 injury, 2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SHOULDER ARTHROSCOPY/ARTHROSCOPIC GLENOID RECONSTRUCTION SURGERY AFTER THE ANCHOR WAS IMPLANTED, THE THREADS BROKE WHEN THE GUIDE WAS PULLED OUT. 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 20608755 ↗
• MalfunctionMar 28, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE ANCHOR OF THE DEVICE BROKE DURING IMPLANTATION. NO BROKEN PARTS REMAINED INSIDE 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 13928378 ↗
• InjuryFeb 11, 2020Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY ON (B)(6) 2019 A HARDWARE FAILURE OCCURRED WITH AN ARTHREX IMPLANT THAT BECAME LOOSE INSIDE THE PATIENT. DUE TO THE FAILURE A REVISION SURGERY ON (B)(6) 2019 WAS NECESSARY. ADDITIONAL INFORMATION OBTAINED 14-JAN-2020. FURTHER INFORMATION WERE PROVIDED BY THE CUSTOMER. IT WAS REPORTED THAT THE CUSTOMER USES THE SOS SYSTEM TO FOLLOW UP ON THE PATIENT WHO INDEED HAD COMPLICATIONS. HOWEVER IT WAS REPORTED THAT THE EVENT WAS NOT RELATED TO THE ARHTREX ANCHOR. THE PATIENT HAD OTHER COMPLICATIONS WHICH RESULTED IN THE LOOSE ANCHOR. DR (B)(6) HAS REMOVED THE ANCHOR DUE TO THE COMPLICATIONS BUT STATED THAT THE PROBLEM ITSELF WAS NOT RELATED TO THE ANCHOR ITSELF. ADDITIONAL INFORMATION OBTAINED 24-JAN-2020. THE EXPLANTED PART NUMBER HAS BEEN PROVIDED: AR-2324PSLM-1, PEEK SWIVELOCK SP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9693153 ↗