Arthrex® AR-8933-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867049499), received between Jun 9, 2017 and Jun 9, 2017 — 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.

• InjuryJun 9, 2017Break

  IT WAS REPORTED VIA FAX THAT A PATIENT UNDERWENT A SURGERY IN (B)(6) 2013 FOR SPLAY FOOT AND SEVERE RIGHT HALLUX VALGUS. DURING THE SURGERY A METAL PLATE AND SIX SCREWS WERE IMPLANTED (REPORTED TO BE MANUFACTURED BY ARTHREX). IN (B)(6) 2016 SWELLING WAS NOTED AT THE SURGICAL SITE AND AN X-RAY REVEALED THAT TWO OF THE SIX SCREWS HAD BROKEN. ONE SCREW WAS REPORTED TO BE PRESSING AGAINST THE TOP OF THE FOOT CAUSING THE REPORTED SWELLING. PATIENT UNDERWENT A SECOND SURGERY ON (B)(6) 2016 DURING WHICH TIME THE ORIGINAL PLATE AND SCREWS WERE REMOVED AND REPLACED. REPORTER STATES SURGERY HAS REQUIRED DOUBLE THE HEALING TIME, LOSS OF EMPLOYMENT, INABILITY TO EXERCISE AND POSSIBLE FUTURE NERVE DAMAGE. REPORTER ALSO STATES PATIENT'S FOOT LOOKS WORSE THAN PRIOR TO THE SECOND SURGERY AND THAT THE SPACE BETWEEN THE BIG TOE AND SECOND TOE IS GREATER THAN BEFORE THE SECOND SURGERY. ADDITIONAL INFORMATION OBTAINED 12/7/2016: OP REPORT (B)(6) 2016 NOTED: PATIENT IS ACTIVE IN HER SPORTS AND X-RAY REVEALED A POSSIBLE PSEUDOARTHROSIS. THE POTENTIAL PSEUDOARTHROSIS WAS CONFIRMED DURING THE REVISION. THE OP REPORT NOTED: WE IDENTIFIED THE PSEUDOARTHROSIS AND THE NEW SCREW(S) PLATE SYSTEM WERE IMPLANTED

  Patient problems: Loss of Range of Motion; Nerve Damage; Swelling

  MAUDE report 6629183 ↗