Arthrex® AR-8835-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867047495), received between Aug 13, 2019 and Aug 13, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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.

• InjuryAug 13, 2019Break

  IT WAS REPORTED VIA EMAIL THAT THE FACILITY SUBMITTED A MEDWATCH REPORT ((B)(4)) FOR THE FOLLOWING INCIDENT: THE PATIENT IS (B)(6) YEARS OLD AND HAD A PREVIOUS ANKLE FRACTURE WITH SYNDESMOTIC FIXATION ON (B)(6) 2019. PATIENT HAS ELECTED TO UNDERGO HARDWARE REMOVAL FROM THE SYNDESMOSIS. PROCEDURE: REMOVAL OF ONE SCREW AND SCREW HEAD FROM THE RIGHT LATERAL FIBULAR PLATE. DESCRIPTION OF OPERATIVE PROCEDURE: THE SCREW HEADS WERE IDENTIFIED WITH FLUOROSCOPIC IMAGING. THE MOST DISTAL SCREW WAS NOTED TO HAVE A BROKEN SCREW HEAD. THE SCREW HEAD WAS REMOVED. THE MORE PROXIMAL SYNDESMOTIC SCREW WAS THEN REMOVED COMPLETELY. FLUOROSCOPIC EVALUATION OF THE ANKLE FOUND THE SYNDESMOSIS TO BE STABLE WITHOUT MEDIAL CLEAR SPACE WIDENING. MEDWATCH REPORT PROVIDED NOTED THAT X-RAY VIEWS OF THE RIGHT WERE TAKEN ON (B)(6) 2019. 2 VIEWS OF THE RIGHT ANKLE SHOW STABLE FIXATION WITHOUT HARDWARE FAILURE AT THAT POINT. ADDITIONAL INFORMATION OBTAINED 7/22/2019: THE FACILITY HAS CONFIRMED THAT THE RECORDS INDICATE THE REASON FOR THE SECOND SURGERY WAS THAT THE PATIENT ELECTED TO UNDERGO HARDWARE REMOVAL FROM THE SYNDESMOSIS. THE BROKEN SCREW HEAD WAS DISCOVERED DURING THE SECOND SURGERY. THE ORIGINAL AND SECO

  Patient problems: No Information

  MAUDE report 8887205 ↗