Arthrex® AR-13715-11.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867014886), received between Jun 7, 2018 and Jun 7, 2018 — 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 7, 2018Break

  IT WAS REPORTED THAT THE INITIAL SURGERY WAS COMPLETED SUCCESSFULLY AS PER 6 WEEK POST OP X-RAY. X-RAY WAS SATISFACTORY AND PATIENT WAS DOING WELL AND CLINICALLY NO ISSUES OR CONCERNS AT THIS POINT. PATIENT RETURNED IN 3 WEEKS (9 WEEKS POST SURGERY) WITH SEVERE PAIN. AN X-RAY WAS TAKEN AND SHOWS THAT SCREWS WERE BROKEN DISTALLY IN THE BONE AND NOT AT THE LEVEL OF THE PLATE. X-RAY WAS NOT CLEAR THAT THE FRACTURE WAS COMPLETELY HEALED AND SOME CONCERN THAT THE LATERAL CORTEX CRACK FRACTURE. PER OPERATIVE THE LATERAL SIDE WAS INTACT AND THE FRACTURE WAS SOLID. THERE WAS NOT A CLEAR NON UNION AND ALSO NO LAXITY OF THE FRACTURE AREA. THE PATIENT HAD THE PLATE AND SCREWS EXCHANGED. CLINICAL FOLLOW UP SHOWS GOOD PROGRESS AND THE PAIN IS MUCH IMPROVED. THIS PATIENT HAD SIMULTANEOUS BILATERAL HTO WHICH PER OPERATIVE THERE WAS A CRACK FRACTURE OF THE LATERAL CORTEX ON THE OPPOSITE SIDE WHICH WAS STABILIZED WITH STAPLES. THE PATIENT WAS ADVISED TO HAVE PARTIAL WEIGHT BEARING POST OP AND ALSO ADVISED TO OFF LOAD SLIGHTLY TO THE RIGHT SIDE.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 7577690 ↗