Arthrex® AR-8665-1875Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867257962), received between Jul 19, 2017 and Jul 19, 2017 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 19, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SUBTALAR FUSION CASE THE FOLLOWING ITEMS WERE IMPLANTED: ARTHROCELL, 2.5CC (LINE 198890), 6.5X75MM HEADLESS COMPRESS SCREW (LINE 198892) AND 6.5X80MM HEADLESS COMPRESSION SCREW (LINE 198897). THE PATIENT HAS SINCE DEVELOPED AN INFECTION AT THE SITE. A CULTURE HAS BEEN DONE AND CAME UP NEGATIVE. FOLLOW-UP INVESTIGATION: PATIENT DEVELOPED A FEVER AND FOUL ODOR FROM THE INCISION ON (B)(6) 2017 AND WAS ADMITTED TO THE HOSPITAL FOR IMPLANT REMOVAL, IV ANTIBIOTICS AND CONSULT FOR PICC LINE WITH INFECTIOUS DISEASE DOCTOR. THE CULTURE WAS (B)(6) FOR (B)(6). THE PATIENT WAS DISCHARGED ON (B)(6) 2017 WITH ORAL ANTIBIOTICS AND PICC LINE. PATIENT TO CONTINUE WITH ORAL ANTIBIOTICS AND PICC LINE UNTIL INFECTION HAS RESOLVED. WHEN THE INFECTION RESOLVES THE PATIENT WILL UNDERGO REVISION FUSION WITH AUTOGRAFT.

  Patient problems: Unspecified Infection

  MAUDE report 6724202 ↗