Arthrex® AR-8916CX24-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867219762), received between Jun 23, 2020 and Jun 23, 2020 — 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.

• InjuryJun 23, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE PRODUCT TEAM THAT A SALES REP HAS REPORTED A POSSIBLE PATIENT REACTION INCIDENT INVOLVING AN ARTHREX VOLAR PLATE. THE MATERIAL COMPOSITION INFORMATION WAS PROVIDED TO THE SALES REP, FOR THE SURGEON, BY THE PRODUCT TEAM. ADDITIONAL INFORMATION PROVIDED 6/1/20: THE PATIENT HAD UNDERGONE A DISTAL RADIUS FRACTURE ORIF PROCEDURE ON (B)(6) 2020. THE PATIENT HAD THE INITIAL POST OP VISIT ON (B)(6) 2020 AT WHICH TIME THE PATIENT WAS TAKEN TO THE OR FOR AND IRRIGATION AND DEBRIDEMENT FOR A PRESUMED INFECTION. CULTURES HAS ALL BEEN NEGATIVE: NEGATIVE AEROBIC, ANAEROBIC, FUNGAL AND AFB. SYMPTOMS OF DRAINAGE, BLISTERING, RASHES AND WOUND HEALING ISSUES HAVE ALL BEEN ASSESSED BY THE SURGEON, INFECTIOUS DISEASE AND DERMATOLOGY. PATIENT HAS BEEN TREATED TO DATE WITH STEROIDS AND ANTIBIOTICS (TOPICAL AND ORAL). IT IS UNKNOWN IF PATIENT HAS BEEN TESTED FOR SPECIFIC KNOWN ALLERGIES HOWEVER IT HAS BEEN REPORTED THAT PATIENT HAS DEVELOPED ALLERGIC REACTION TO ALMOST EVERYTHING (ADHESIVE, SUTURE, PREP, MULTIPLE ANTIBIOTICS). THE PATIENT HAS AN ALLERGIST VISIT SCHEDULED FOR (B)(6) 2020. THE FOLLOWING ARE THE ARTHREX DEVICES THAT WERE IMPLANTED DURING THE 3/3/20 PROCEDURE: AR-

  Patient problems: Impaired Healing; Rash; Reaction; Swelling

  MAUDE report 10184155 ↗