Arthrex® AR-1400TBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867016224), received between Sep 14, 2017 and Feb 6, 2023 — classified as 2 injuries.

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

• InjuryFeb 6, 2023Use of Device Problem; Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/18/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1400TB BIO-INTERFERENCE SCREW FULL THREAD, AN AR-1588T ACL TIGHTROPE, (3) AR-2324BCC-2 BIO COMPOSITE SWIVELOCK, (3) AR-4500 MENISCAL CINCH, (4) AR-7200 FIBERWIRE, AND (2) AR-7237 FIBERTAPE WERE ALL IMPLANTED IN THE PATIENT. THIS ACL AND LIGAMENT PROCEDURE TOOK PLACE ON (B)(6) 2023. PATIENT DEVELOPED AN INFECTION POST OPERATIVE AND PATIENT REMAINS ADMITTED TO THE HOSPITAL FOR TREATMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 16302956 ↗
• InjurySep 14, 2017Insufficient Device Problem Information

  AN ARTHREX EMPLOYEE FROM (B)(6) SUBSIDIARY REPORTED THAT A PATIENT HAD A KNEE ARTHROSCOPIC ACL REPAIR WHERE THE SURGEON INSERTED A BIO-INTERFERENCE SCREW, FULL THREAD INTO THE TIBIA. THE PATIENT HAS SINCE DEVELOPED AN INFECTION IN THE OPERATIVE AREA AND IS NOT HEALING PROPERLY. ON (B)(6) 2017, THE SURGEON INTERVENED AND ADVISED THAT THE SCREW IS COVERED WITH TISSUE, THEREFORE, GRAFTED A FEW ALLOGRAFT FLAPS TO HELP CLOSE THE LESION. THE SURGEON STATED DURING THE CASE, THAT HE DOES NOT BLAME THE COMPANY OR THE IMPLANT. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2017. FOLLOW-UP UPDATE FROM ARTHREX (B)(6): RESULT OF CULTURES TAKEN/TYPE OF ORGANISM(S) IDENTIFIED WERE REQUESTED BUT NOT PROVIDED CITING (B)(6) PRIVACY LAWS. THE SURGEON MENTIONED THAT "THE INFECTION WAS EXTERNAL AND THE PATIENT IS GETTING BETTER AND THAT HE DOES NOT BELIEVE THAT THE INFECTION IS RELATED TO THE DEVICE". THIS EVENT WILL NOT BE REPORTED TO THE (B)(6) AUTHORITIES.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 6864157 ↗