Arthrex® AR-1920SNFRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867022843), received between Feb 7, 2022 and Sep 13, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WAS TREATED WITH TWO AR-1920SNF TO REFIXATE THE ACHILLES TENDON IN THE CALCANEUS AFTER REMOVAL OF THE HAGLUND EXOSTOSIS. AFTER THE SURGERY THE PATIENT HAS COMPLAINTS DUE TO IRRITATION AND SWELLING IN THIS AREA. IT WAS FURTHER REPORTED THAT THIS HAS ALREADY BEEN REVISED IN A SECOND SURGERY AND THE SYMPTOMS ARE STILL PRESENT. THE CUSTOMER IS UNSURE WHERE THE PROBLEM IS COMING FROM BUT ASSUMES IT COULD BE THE FIBERWIRE IS CAUSING THE REACTION. NO FURTHER INFORMATION RECEIVED. UPDATE DW 06-SEP-2024: FURTHER INFORMATION WAS PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2023 AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. IT WAS FURTHER REPORTED THAT NOT ALL PARTS OF THE IMPLANT COULD BE REMOVED.

  Patient problems: Swelling/ Edema

  MAUDE report 20213326 ↗
• InjurySep 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WAS TREATED WITH TWO AR-1920SNF TO REFIXATE THE ACHILLES TENDON IN THE CALCANEUS AFTER REMOVAL OF THE HAGLUND EXOSTOSIS. AFTER THE SURGERY THE PATIENT HAS COMPLAINTS DUE TO IRRITATION AND SWELLING IN THIS AREA. IT WAS FURTHER REPORTED THAT THIS HAS ALREADY BEEN REVISED IN A SECOND SURGERY AND THE SYMPTOMS ARE STILL PRESENT. THE CUSTOMER IS UNSURE WHERE THE PROBLEM IS COMING FROM BUT ASSUMES IT COULD BE THE FIBERWIRE IS CAUSING THE REACTION. NO FURTHER INFORMATION RECEIVED. ***UPDATE DW 06-SEP-2024: FURTHER INFORMATION WAS PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON 01-JUN-2023 AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. IT WAS FURTHER REPORTED THAT NOT ALL PARTS OF THE IMPLANT COULD BE REMOVED.

  Patient problems: Swelling/ Edema

  MAUDE report 20213200 ↗
• MalfunctionFeb 7, 2022Break

  ON (B)(6) 2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA E-MAIL THAT AN AR-1920SNF SUTURE ANCHOR SUTURES FAILED/BROKE. THIS OCCURRED DURING A KNEE ARTHROSCOPIC PROCEDURE ON (B)(6) 2021. THE ANCHOR WAS REMOVED AND THE CASE WAS COMPLETED BY USING A NEW AR-1920SNF.

  Patient problems: Insufficient Information

  MAUDE report 13471800 ↗