Arthrex® AR-8835-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867047501), received between Aug 13, 2019 and Feb 6, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2023Break

  ON 1/17/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA MEDWATCH EMAIL THAT AN AR-8835-60 LOW PROFILE SCREW HEAD BROKE DURING THE PROCEDURE ON (B)(6) 2022. THE BODY OF THE SCREW REMAINS IN THE PATIENT AND BROKEN HEAD WAS RETRIEVED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 16303294 ↗
• InjuryAug 13, 2019Break; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA EMAIL THAT THE FACILITY SUBMITTED A MEDWATCH REPORT ((B)(4)) FOR THE FOLLOWING INCIDENT: THE PATIENT IS 47 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 SECOND S

  Patient problems: No Information

  MAUDE report 8887213 ↗