Arthrex® AR-8724-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867045118), received between Mar 22, 2017 and Aug 26, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2019Break; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A LEFT FOOT TENDON REPAIR WITH BONE MARROW ASPIRATION ON (B)(6) 2019. DURING THE PROCEDURE THE PATIENT STATES THAT AN ARTHREX L-PLATE AND SCREWS WERE IMPLANTED ALONG WITH A WEDGE AND GRAFT. PATIENT STATED ONE OF THE SCREWS HAS BROKEN, LEAVING THE TOP PORTION LOOSE IN THE FOOT. PATIENT IS HAVING TREMENDOUS PAIN AND THE BREAKAGE WILL RESULT IN NEEDING A SECOND PROCEDURE. THE PATIENT ONLY HAD TWO OF THE SCREW PART NUMBERS AT TIME OF REPORT, AR-8724-16 (QTY 1) AND AR-8724-14 (QTY 2). IT IS UNKNOWN IF ONE OF THESE TWO SCREWS MAY BE THE BROKEN ONE OF IF THERE MAY BE OTHER SCREWS THAT WERE ALSO IMPLANTED PATIENT WILL REACH OUT TO THE SURGICAL FACILITY TO OBTAIN THE IMPLANT LOG AND PROVIDE TO ARTHREX UPON RECEIPT. PATIENT ALSO REPORTED THAT SHE HAD ROLLED HER ANKLE AT HER HOME (RENTAL) AND REPORTED IT TO HER LANDLORD AND REPORTED THE NOW DISCOVERED BROKEN SCREW ISSUE. LANDLORD STANCE ON THE ISSUE WAS THAT ROLLING HER ANKLE SHOULD NOT CAUSE THE SCREW TO BREAK BECAUSE TITANIUM SHOULD NOT BREAK, LANDLORD INSTRUCTED PATIENT TO CONTACT THE MANUFACTURER (ARTHREX). UPDATED INFORMATION OBTAINED (B)(6) 2019: PATIENT IS STILL ATTEMPTING TO OBTAIN THE

  Patient problems: Pain

  MAUDE report 8930581 ↗
• InjuryMar 22, 2017Break; Device Dislodged or Dislocated

  IT WAS REPORTED ON 9/15/2016 BY A PATIENT VIA THE ARTHREX WEBSITE THAT THE PATIENT HAD UNDERGONE FOOT SURGERY (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 2/28/2017: THE R

  Patient problems: Pain; Swelling

  MAUDE report 6424843 ↗