Arthrex® AR-8724-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867045156), received between Mar 22, 2017 and Aug 27, 2020 — classified as 2 injuries.

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 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 27, 2020Material Fragmentation

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A PROCEDURE (B)(6) 2020. THE FIRST WEEK OF (B)(6) 2020 THE PATIENT HAD A FOLLOW UP VISIT AT THE SURGEON'S OFFICE AND X-RAYS TAKEN DURING THE FOLLOW UP SHOWED A FOREIGN BODY IS PRESENT. THE ITEM HAD NOT BEEN SEEN ON THE INTRAOPERATIVE X-RAYS TAKEN AT THE TIME OF PROCEDURE. IT WAS ALSO REPORTED THAT THE FOREIGN BODY IS NOT CAUSING ANY PAIN OR DISCOMFORT TO THE PATIENT. SURGEON BELIEVES THAT THE FOREIGN BODY MAY BE A THIN SHAVING FROM THE NARROW ULNAR PLATE/PLATE SCREWS THAT HAD BEEN IMPLANTED. SURGEON ALSO INDICATED THAT HE HAS SEEN THIS OCCUR PREVIOUSLY WITH THE ARTHREX SYSTEM THAT WAS USED. (INFORMATION HAS BEEN REQUESTED REGARDING THESE INSTANCES.) THE SHAVING WAS NOT NOTICED AT THE TIME OF OCCURRENCE TO DETERMINE THE SPECIFIC PRODUCT THE SHAVING MAY HAVE COME FROM. AT THIS TIME THE SURGEON DOES NOT HAVE PLANS TO REMOVE THE HARDWARE OR FOREIGN BODY BUT THE SALES REPRESENTATIVE HAS REQUESTED THAT THE SURGEON NOTIFY HIM IF A SECOND SURGERY IS SCHEDULED. THE FOLLOWING ARE THE PLATE AND SCREWS THAT WERE USED DURING THE (B)(6) 2020 PROCEDURE: AR-8916VNL-03, VOLAR DISTAL RADIUS PLATE, LOT 10440051. AR-8724-18, LOW PROFILE SCREW, LOT W652321.

  Patient problems: Foreign Body In Patient

  MAUDE report 10460581 ↗
• InjuryMar 22, 2017Break; Difficult to Remove

  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)(4)), AR-8724-16 ((B)(4)), AR-8724-12 ((B)(4)), AR-8724-14 ((B)(4)), AR-8724-18 ((B)(4)), AR-8930-12 ((B)(4)) AND AR-8724-12PT ((B)(4)). 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 6424852 ↗