Arthrex® AR-8643-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867126046), 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 198894), 6.5X80MM HEADLESS COMPRESS SCREW (LINE 198895) AND 4.3X55MM HEADLESS COMPRESSION SCREW (LINE 198896). THE PATIENT HAS SINCE DEVELOPED AN INFECTION AT THE SITE. A CULTURE HAS BEEN DONE AND CAME UP NEGATIVE. FOLLOW UP INVESTIGATION: IT WAS REPORTED THAT THE PATIENT DEVELOPED DRAINING AND ODOR FROM THE SURGICAL WOUND. ON (B)(6) 2017 THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR IMPLANT REMOVAL, WOUND CARE, IV ANTIBIOTICS AND PICC LINE FOR OUTPATIENT IV ANTIBIOTICS. THE PATIENT'S CULTURE WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE PATIENT WILL CONTINUE IV ANTIBIOTIC VIA PICC LINE FOR A MINIMUM OF 6 WEEKS DUE TO DONE INVOLVEMENT. NO FURTHER SURGERY IS INDICATED AT THIS TIME.

  Patient problems: No Information

  MAUDE report 6724216 ↗