Arthrex® AR-8830-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867047174), received between Feb 26, 2025 and Feb 26, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 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.

• MalfunctionFeb 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT CONTACTED CUSTOMER SERVICE REQUESTING THE MATERIAL COMPOSITION OF A RIGHT FIBULA NAIL 3.0 BY 130 MM. NO ALLEGATION OF PRODUCT DEFICIENCY OR ADVERSE EVENT WAS REPORTED WITHIN THIS INQUIRY. ON (B)(6) 2025, THE PATIENT REPORTED VIA PHONE TO HAVE BEEN EXPERIENCING DIFFICULTY WALKING AND CONSTANT PAIN. THE PATIENT STATED THAT THE SCREWS APPEAR TO BE PROTRUDING AND CAN BE SEEN ON THE SKIN OF THE KNEE. THE PATIENT UNDERWENT TIBIAL SURGERY DUE TO AN ACCIDENT ABOUT A YEAR AND A HALF AGO IN WHICH SCREWS AND THE TIBIAL NAIL WAS IMPLANTED. THE PATIENT REPORTS TO BE HIGHLY ALLERGIC TO TITANIUM; HOWEVER, POST OPERATION, THE PATIENT HAD A THREE WEEKLONG METAL TESTING, WHICH CAME BACK NEGATIVE FOR ALLERGIES. THE PATIENT WAS NOT TESTED FOR ALLERGIES PRIOR TO THE SURGERY. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 2/14/2025: IT WAS REPORTED BY THE PATIENT VIA EMAIL THAT AN AR-8973DS FIBULOCK IMPLANT SYSTEM, A 1109-300 TIBIAL NAIL, AN 8001-040 CAPTURED CORTICAL SCREW, TWO 8001-034 CAPTURED CORTICAL SCREW, TWO 8001-044 CAPTURED CORTICAL SCREW, AN AR-8973L-30-130 ARTHREX FIBULOCK NAIL, AN AR-8830-16 FULLY THREADED CANCELLOUS SCREW, AND AN AR-89

  Patient problems: Pain

  MAUDE report 21471138 ↗