Arthrex® AR-7227-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867041561), received between Apr 18, 2019 and Jul 17, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (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.

• MalfunctionJul 17, 2025Material Frayed; Material Frayed

  ON 06/20/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-7227-01 FIBERWIRE® #3-0 FRAYED DURING THE CASE, PATIENT NOT AFFECTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529914 ↗
• InjuryApr 18, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  A PATIENT REPORTED THAT ON (B)(6) 2018 SHE HAD UNDERGONE TWO DIFFERENT PROCEDURES ON HER RIGHT HAND ON DIFFERENT FINGERS . ONE PROCEDURE HAS HAD NO ISSUES. THE RIGHT INDEX FINGER WHICH HAD THE EXTENSOR TENDON REPAIR IS NOT HEALING. THE FINGER HAS HAD PUSS DRAINING AND HAS CONTINUALLY BEEN HAVING PIECES OF THE SUTURES PUSHING OUT THROUGH THE SKIN, WITH THE MOST RECENT PIECE BEING APPROXIMATELY 2 INCHES LONG ON (B)(6) 2019. PATIENT HAS BEEN PRESCRIBED TWO COURSES OF ANTIBIOTICS. PATIENT DEVELOPED COLITIS AND C-DIFF FROM THE ANTIBIOTICS RESULTING IN HER HAVING TO GO TO THE HOSPITAL. PATIENT HAS CONTINUED TO SOAK HER FINGER ONCE PER DAY AND BELIEVES ALL PIECES OF THE SUTURES MAY HAVE NOW COME OUT AS THE PUSS APPEARS TO HAVE DISSIPATED. PATIENT'S ONLY KNOWN ALLERGY IS IODINE CONTRAST. PART NUMBER WAS NOT KNOWN AT THE TIME OF INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN ACCEPTED. ADDITIONAL INFORMATION OBTAINED (B)(6) 2019: THE PROCEDURES PERFORMED ON (B)(6) 2018 WERE RIGHT INDEX FINGER PRIMARY TENDON REPAIR ZONE 5 AND RIGHT MIDDLE FINGER EXTENSOR TENDON CENTRALIZATION WITH RECONSTRUCTION OF THE RADIAL SAGITTAL BAND. DURING THE PROCEDURE THE SURGEON USED ARTHREX 3.0 FIBERWIRE. SPECIFI

  Patient problems: Bacterial Infection; Impaired Healing; Purulent Discharge

  MAUDE report 8526623 ↗