Arthrex® AR-8724-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867045095), received between Mar 22, 2017 and Dec 2, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2020Difficult to Advance

  IT WAS REPORTED CONSTRUCTIVE FEEDBACK WAS RECEIVED FROM A SURGEON REGARDING THE 2.4 CORTICAL SCREW (AR-8724) IN THE CFS SET. THE SURGEON WAS TREATING A FRACTURE ACROSS THE MIDFOOT AND SECOND METATARSAL, AND WHAT THEY THOUGHT WOULD BE A 20 MIN CASE, TURNED INTO TWO HOURS AND THE SURGEON HAVING TO BAIL TO ANOTHER SYSTEM. THE AMOUNT OF AXIAL LOAD AND FORCE TO GET THE 2.4 CORTICAL SCREWS TO ADVANCE WAS SIGNIFICANT, AND THE SURGEON COULD NOT GET THE 2.4 CORTICAL SCREWS TO ADVANCE WITHOUT LOSING THEIR REDUCTION AS A RESULT OF HAVING TO REALLY LEAN INTO THE SCREWDRIVER TO ADVANCE THE SCREW. THE SURGEON TRIED TO MAKE IT WORK AND WANTED TO STICK WITH ARTHREX FOR THEIR IMPLANT, BUT HAD TO BAIL. ONCE THE SURGEON WENT TO ANOTHER MANUFACTURER'S SYSTEM, THE SCREWS WENT IN WITHOUT ANY ISSUE. THE SURGEON MENTIONED THEY NOTICED THE SCREW TIPS HAVE MORE OF A SNUB NOSE AND THEY ARE NOT SURE IF THE SELF-TAPPING FLUTES WHERE GRABBING. IT WAS CONFIRMED THAT THE CORRECT DRILL BIT WAS USED. ADDITIONAL INFORMATION OBTAINED 11/11/20: DATE OF THE SURGERY WAS (B)(6) 2020. THE PART NUMBERS OF THE ARTHREX 2.4 SCREWS ATTEMPTED WERE: AR-8724-08, AR-8724-10 AND AR-8724-12. THE SPECIFIC LOT NUMBERS OF THE SCREWS AR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10934510 ↗
• InjuryJan 9, 2020Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON HAD TO REMOVE THE WRIST SPANNING PLATE, AR-8916SPN, BECAUSE THE SCREWS WERE BACKING OUT OF THE DISTAL HOLES. NO FURTHER INFORMATION, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: CASE DATE OF IMPLANTATION: (B)(6) 2019. CASE DATE OF EXPLANTATION: NOT YET DETERMINED THE FOLLOWING SCREWS WERE ALSO EXPLANTED DURING THE REVISION: AR-8724-12 LOT: 2542021. AR-8724V-12 LOT: 2605841. AR-8724V-18 LOT: 2605831. AR-8935-14 LOT: 10176201. AR-8935-14 LOT:10249431. THE SPECIFIC DATE OF THE SECOND SURGERY (EXPLANT) IS UNKNOWN, HOWEVER IT IS KNOWN THAT THE DATE WAS PRIOR TO (B)(6) 2019. FOR REPORTING PURPOSES (B)(6) 2019 HAS BEEN ENTERED AS THE DATE OF EVENT.

  Patient problems: Failure of Implant

  MAUDE report 9569883 ↗
• InjuryMar 22, 2017Break; Device Dislodged or Dislocated

  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:

  Patient problems: Pain; Swelling

  MAUDE report 6424833 ↗