Arthrex® AR-8944-PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867053182), received between Oct 9, 2018 and Oct 9, 2018 — classified as 1 injury.

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

• InjuryOct 9, 2018Crack

  IT WAS REPORTED, VIA A PATIENT LETTER RECEIVED 9/26/18, THAT THE PATIENT HAD A FOOT PROCEDURE IN (B)(6) 2017 DURING WHICH AN ARTHREX AR-8944-P (LOW PROFILE STRAIGHT MTP PLATE) WAS IMPLANTED AND IN (B)(6) 2017 IT WAS DISCOVERED THE PLATE HAD CRACKED IN HALF. PATIENT STATED THAT POST OP THE ORIGINAL (B)(6) 2017 PROCEDURE SHE WAS WEARING A MEDICAL BOOT AND FOLLOWING ALL INSTRUCTIONS BY HER DOCTOR. PATIENT SUFFERED FROM PAIN AND SWELLING AND WAS REFERRED TO A FOOT SURGEON SPECIALIST WHO HAD TO REMOVE THE BROKEN PLATE AND INSERT ANOTHER PLATE TO ENSURE THAT THE FOOT HEALED PROPERLY. ADDITIONAL INFORMATION OBTAINED 9/26/18: IN (B)(6) 2017, PATIENT UNDERWENT A BUNION PROCEDURE WHICH DID NOT FUSE. THE SURGEON, THEN PERFORMED A SECOND PROCEDURE (B)(6) 2017. DURING THE SECOND PROCEDURE AN AR-8944-P (LOW PROFILE STRAIGHT MTP PLATE) WAS IMPLANTED. PATIENT HAD BEEN WEARING A MEDICAL BOOT AND FOLLOWING ALL POST-OP PROTOCOL. IN (B)(6) 2017 PATIENT WENT FOR A FOLLOW UP TO DETERMINE IF THE BOOT COULD COME OFF AND AN X-RAY DISCOVERED THAT THE PLATE HAD CRACKED INSIDE HER FOOT. PATIENT WAS THEN REFERRED TO A SPECIALIST WHO FELT IT WOULD BE BEST IF SHE COULD LEAVE THE BROKEN PLATE IN WHILE THE FUSING

  Patient problems: Pain; Swelling

  MAUDE report 7947212 ↗