Arthrex® AR-13420-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867012523), received between Feb 12, 2020 and Feb 12, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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 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 12, 2020Difficult to Remove

  IT WAS REPORTED THAT DURING AN IBALANCE HTO CASE, THE AR-13419-02 COLLET NUT CROSS-THREADED ONTO THE AR-13420-01 BIPLANAR ALIGNMENT MOUNT AND COULD NOT BE REMOVED. THE AR-13419-01 HINGE PIN AND AR-13420-02 BIPLANAR ALIGNMENT BAR WERE ALSO PART OF THE DEVICE. BECAUSE THE NUT COULD NOT BE REMOVED, THEY COULD NOT PUT IN ANOTHER GUIDE TO DRILL THE KEYHOLE. THE DEVICES WERE REMOVED FROM THE PATIENT AND THEY USED FREEHAND FOR THE KEYHOLE DRILL HOLES AND THE OSTEOTOMY. THE IMPLANT WAS DONE SUCCESSFULLY TO COMPLETE THE CASE. THERE WAS AN ADDITIONAL INCISION NEEDED ON THE LATERAL SIDE OF THE FIBIA TO CREATE AN ADDITIONAL PIVOT FOR THE OSTEOTOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9700043 ↗