Arthrex® AR-8953-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867055155), received between Jan 23, 2018 and Jan 23, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON HIS RIGHT FOOT ON (B)(6) 2017 WHERE A 4MM PROXIMAL WEDGE PLATE (LINE: (B)(4)) AND A 3.5MM HEADLESS SCREW FOR CHEVRON (LINE: (B)(4)) WERE IMPLANTED. ALSO IMPLANTED WAS A 2.4 HEADED SCREW FOR K-WIRE BUT REPORTER DOES NOT BELIEVE THIS IS AN ARTHREX PRODUCT. THE PATIENT BEGAN TO EXPERIENCE HEAT AND SWELLING IN HIS FOOT ABOUT 2 MONTHS POST-OP. THE SURGEON IS CONSIDERING REMOVING THE HARDWARE. PATIENT'S ONLY KNOWN DRUG ALLERGY IS TO NEOMYECIN ANTIBIOTIC OINTMENT. FOLLOW-UP INVESTIGATION: DATE OF SURGERY WAS (B)(6) 2017, PATIENT IS A MALE, SURGERY WAS ON RIGHT FOOT. PATIENT HAS SIGNIFICANT SWELLING TO DATE, 4.5 MONTHS AFTER SURGERY. DECISION TO REMOVE THE HARDWARE HAS NOT BEEN MADE. PATIENT IS STILL EXPERIENCING THE LOCALIZED HEAT AND SWELLING AT THE SURGICAL SITE. PART NUMBERS HAVE NOW BEEN OBTAINED AND THE MATERIAL COMPOSITION OF EACH IMPLANT HAS BEEN PROVIDED.

  Patient problems: Swelling

  MAUDE report 7211693 ↗