Arthrex® AR-7209Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867041370), received between Feb 8, 2019 and Nov 14, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 10/24/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-2923PHS SUTURE ANCHOR DOES NOT PERFORM ITS FUNCTION, AND AN AR-7209 FIBERSTICK TORE. THIS OCCURRED DURING A HIP ARTHROSCOPY PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20685993 ↗
• InjuryFeb 8, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS ORIGINALLY REPORTED THAT THE PATIENT HAD SUFFERED A SHOULDER INJURY IN 2011 WHILE WORKING. ON (B)(6) 2013 SHE UNDERWENT A SHOULDER PROCEDURE DURING WHICH AN ARTHREX AR-7209, LOT :10667 (#2 FIBERSTICK, #2 FIBERWIRE) AND AN AR-7200 LOT: UNKNOWN (FIBERWIRE BRAIDED PB #2 SUTURE, BLUE W/NEEDLE) WERE UTILIZED. FOLLOWING THE (B)(6) 2013 SURGERY THE PATIENT BEGAN TO EXPERIENCE REACTION TYPE SYMPTOMS WHICH THE PATIENT REPORTED TO ARTHREX ON (B)(6) 2014 ((B)(4), MEDWATCH 1220246-2014-00200). AT THAT TIME THE PATIENT REPORTED THAT SHE HAD BEEN HAVING HIVES WITH A POSSIBLE REACTION TO THE FIBERWIRE. THE PATIENT ALSO REPORTED THAT SHE HAD BEEN SEEN BY A DERMATOLOGIST BUT THE OUTCOME HAD BEEN INCONCLUSIVE AT THAT TIME. NO FURTHER INFORMATION WAS PROVIDED TO ARTHREX. ON JANUARY 9, 2019, ARTHREX RECEIVED A CD FROM THE PATIENT CONTAINING VOLUMINOUS MEDICAL RECORDS. THE MEDICAL RECORDS NOTE THE PATIENT CONTINUED TO HAVE ISSUES FOLLOWING HER (B)(6) 2013 RIGHT SHOULDER SURGERY INCLUDING ANAPHYLACTIC SHOCK EPISODES, ANGIOEDEMA AND URTICARIA. THE PATIENT WAS SEEN BY MULTIPLE MEDICAL PROFESSIONALS TO DETERMINE WHAT WAS CAUSING HER FREQUENT EPISODES OF ANAPHYLAXIS. IT WAS IDENTIFIED VIA A PATCH TES

  Patient problems: Anaphylactic Shock; Patient Problem/Medical Problem; Reaction; Urticaria

  MAUDE report 8321453 ↗