Arthrex® AR-8963-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867229341), received between Nov 7, 2022 and Nov 7, 2022 — classified as 1 malfunction.

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

• MalfunctionNov 7, 2022Incorrect Measurement; Positioning Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8963-01 DEPTH GUIDE MIS MEASURED. THIS OCCURRED ON (B)(6) 2022 DURING A PILON FX WHEN REVIEWING THE FINAL XRAY IT WAS FOUND THAT THE SCREWS LENGTHS WERE MUCH SHORTER THAN THE MEASUREMENT OF THE DEPTH GAUGE. THE SCREWS WERE REMOVED AND REMEASURED WITH A DIFFERENT DEPTH GAUGE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION PROVIDED ON 10/19/2022, IT WAS REPORTED THAT ADDITIONAL ANESTHESIA WAS ADMINISTERED DUE TO THE 15 MINUTE DELAY. A WORKING DEPTH GAUGE WAS BROUGHT IN TO COMPLETE THE CASE. THE GAUGE WAS MEASURING 10MM SHORT FOR EVERY SCREW LENGTH. WHEN THE DEPTH GAUGE IS MEASURING AT THE 10MM YOU CAN'T SEE THE METAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743538 ↗