Arthrex® AR-8724-12PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867045101), received between Mar 22, 2017 and Mar 22, 2017 — 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 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.

• InjuryMar 22, 2017Break

  IT WAS REPORTED ON (B)(6) 2016 BY A PATIENT VIA THE ARTHREX WEBSITE THAT THE PATIENT HAD UNDERGONE FOOT SURGERY ON (B)(6) 2015. SURGERY WAS LEFT PROXIMAL BUNIONECTOMY IN CONJUNCTION WITH 2ND MTP RECONSTRUCTION FOLLOWING DISLOCATION AND PRIOR PODIATRIC MANAGEMENT. DURING THE SURGERY THE FOLLOWING PARTS WERE IMPLANTED: AR13200M-055R ((B)(6)), AR-8724-16 ((B)(6)), AR-8724-12 ((B)(6)), AR-8724-14 ((B)(6)), AR-8724-18 ((B)(6)), AR-8930-12 ((B)(6)) AND AR-8724-12PT ((B)(6)). ON (B)(6) 2016, PATIENT FOLLOWED UP WITH SURGEON DUE TO RECENT ONSET OF LEFT MID-FOOT PAIN AND SWELLING. MEDICAL RECORDS NOTED THAT UPON EXAMINATION OF THE LEFT FOOT THERE WAS PAIN AT THE 1ST TMT AND PROXIMAL OSTEOTOMY SITE WITH VISIBLE SWELLING. THERE WAS NO ERYTHEMA, DRAINAGE OR OTHER EVIDENCE OF INFECTION. X-RAY RESULTS NOTED THERE IS BROKEN HARDWARE (PROXIMAL BUNION PLATE - AR-13200M-055R) WITH QUESTION OF NON-UNION. SURGEON HAS RECOMMENDED A PROXIMAL LEFT BUNION HARDWARE REMOVAL WITH A PLAN TO PROCEED WITH A LAPIDUS FUSION IF IN FACT THE OSTEOTOMY IS INCOMPLETE. PATIENT REVISION IS TENTATIVELY SCHEDULED FOR EARLY 2017 DUE TO PATIENT LACK OF AVAILABLE TIME OFF FROM WORK. ADDITIONAL INFORMATION RECEIVED 2/28/17: T

  Patient problems: Foreign Body In Patient; Pain; Swelling

  MAUDE report 6424862 ↗