Arthrex® AR-8963P-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867221024), received between Dec 10, 2019 and Dec 10, 2019 — classified as 1 injury.

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.

• InjuryDec 10, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN POSTERIOR MALLEOLAR FRACTURE REDUCTION SURGERY THE ARTHREX POSTERIOR DISTAL TIBIA PLATE - AR-8963P-05 - BATCH 5261808 WAS USED. UPON INSERTION OF SCREW INTO THE OBLONG HOLE, THE SCREW PASSED RIGHT THROUGH THE PLATE RESULTING IN LOSS OF FRACTURE REDUCTION AND THE USE OF THE PLATE AS A BUTTRESS. THE SURGEON HAD TO RESORT TO 46MM SCREWS WITH WASHERS (AR-8840C-46 + AR-8870W X 3) TO REDUCE THE FRACTURE. AS A RESULT THE PATIENT WILL BE NON WEIGHT BEARING FOR APPROX 6 WEEKS. NO FURTHER INFORMATION RECEIVED. UPDATE 22-NOV-2019: A 2.5MM DRILL WAS USED IN PREPARATION FOR A 3.5MM CORTICAL SCREW. THE IMPLANT WAS PUT INTO THE POSTERIOR DISTAL TIBIA.

  Patient problems: No Code Available

  MAUDE report 9443929 ↗