Arthrex® AR-8545-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867124509), received between Feb 25, 2020 and Feb 25, 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 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.

• InjuryFeb 25, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT HAD SUSTAINED A WORK INJURY ON (B)(6) 2019, INJURING A VARIETY OF BODY PARTS IN THAT FALL. PATIENT SUSTAINED INJURIES TO HIS RIGHT LOWER EXTREMITY. SINCE THE INJURY THE PATIENT HAS UNDERGONE SEVERAL PROCEDURES ON HIS RIGHT LOWER EXTREMITY. ON (B)(6) 2019 - EXTERNAL FIXATOR IMPLANTED. AT SOME POINT AFTER THE INITIAL SURGICAL PROCEDURE ON (B)(6) 2019, PATIENT'S RIGHT LOWER EXTREMITY BECAME SEVERELY INFECTED. ON (B)(6) 2019 - EXTERNAL FIXATOR REMOVED AND ORIF CONDUCTED ON RIGHT TIBIAL PILON. THE PRODUCT IMPLANTED IN THE PATIENT DURING THE APRIL PROCEDURES WERE ANOTHER MANUFACTURER'S PRODUCT (NON-ARTHREX). ON (B)(6) 2019 - IRRIGATION AND DEBRIDEMENT, HARDWARE REMOVAL, INSERTION OF ANTIBIOTIC BEADS AND SPACER. ON (B)(6) 2019 - IRRIGATION AND DEBRIDEMENT, RE-INSERTION OF ANTIBIOTIC BEADS AND SPACER. ON (B)(6) 2019 - DEBRIDEMENT AND PREPARATION OF WOUND, SKIN TRANSFER FROM RIGHT THIGH, EXCHANGE OF ANTIBIOTIC SPACER. PATIENT WAS TREATED FOR INFECTION AFTER THE (B)(6) 2019 PROCEDURES UNTIL JUST PRIOR TO THE (B)(6) 2019 PROCEDURE WHERE ARTHREX PRODUCTS WERE IMPLANTED. ON (B)(6) 2019 - IRRIGATION AND DEBRIDEMENT, ANTIBIOTI

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9751141 ↗