Arthrex® AR-8730-24HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867127012), received between Feb 21, 2018 and Jun 27, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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 16, 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.

• InjuryJun 27, 2018Break

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE, DURING REMOVAL OF A 3.5MM COMPRESSION FT SCREW, THE DRIVER TIP BROKE. THE SURGEON HAD PLACED A GUIDE PIN IN THE SCREW TO GUIDE THE DRIVER INTO THE SCREW, SO WHEN THE DRIVER BROKE, THE BROKEN PIECE STAYED ON THE GUIDE PIN AND WAS EASILY RETRIEVED FROM THE PATIENT. TO COMPLETE THE SCREW REMOVAL, THE SURGEON OPENED UP THE KNEE AND COMPLETED THE HARDWARE REMOVAL USING THE NON-CANNULATED T10 HEX DRIVER THAT WE ALSO HAD IN THE SET. ADDITIONAL INFORMATION PROVIDED 6/26/2018: PATIENT UNDERWENT 11 MONTHS POST-OP REVISION FOR KNEE COMPARTMENT PAIN, DOC WAS UNSURE IF THE SCREW WAS CAUSING THIS ISSUE BUT THE PATIENT'S PAIN PERSISTED. HE WANTED TO SEE WHAT WAS GOING ON IN THE KNEE AND SINCE HE WAS GOING IN, HE WOULD REMOVE THE SCREW. REMOVED AN AR-8730-XXH, SURGEON BELIEVED THE SIZE WAS 24MM IN LENGTH. ADDITIONAL INFORMATION PROVIDED 6/27/2018: THE ORIGINAL DOS WAS (B)(6) 2017. SCREW REMOVED WAS AN AR-8730-24H, LOT: 10029598.

  Patient problems: Pain

  MAUDE report 7642682 ↗
• InjuryJun 14, 2018Break

  IT WAS REPORTED THAT DURING A NAVICULAR FRACTURE CASE, THE SURGEON PRE-DRILLED WITH A 2.7 DRILL BIT FOR A 3.5 HEADLESS SCREW. DURING INSERTION, THE SCREW BROKE ABOUT 10MM INTO THE NAVICULAR. THE SURGEON WAS UNABLE TO DRIVE THE SCREW OUT OR REMOVE IT. ABOUT 14MM OF THE SCREW WAS LEFT IN THE BONE AND THE SURGEON ENDED UP OPENING A SYNTHES SMALL FRAGMENT TRAY AND USED A 4.0MM SCREW FROM THERE. PATIENT IS FEMALE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7600188 ↗
• InjuryFeb 21, 2018Break

  IT WAS REPORTED BY A WORKERS COMPENSATION EXCHANGE STAFF MEMBER, THROUGH THE ARTHREX WEBSITE, THAT A PATIENT HAD WRIST SURGERY ON (B)(6) 2017. DURING THE PROCEDURE AN ARTHREX CANNULATED SCREW WAS PUT IN HIS WRIST. PATIENT WAS STILL IN A PERIOD OF RECOVERY WHEN THE DOCTOR FOUND THAT HIS HARDWARE FAILED (BROKE). NO INFORMATION HAS BEEN PROVIDED INITIALLY REGARDING IF A REVISION SURGERY WAS PERFORMED OR HAS BEEN SCHEDULED. FOLLOW-UP INVESTIGATIONS: OP REPORT (B)(6) 2018: PATIENT HAD SUFFERED AN ON THE JOB ACCIDENT SEVERAL WEEKS PRIOR TO HIS (B)(6) 2017 PROCEDURE FOR LEFT WRIST CAPITATE LUNATE FUSION. DURING THIS PROCEDURE AN ARTHREX 24 MM CANNULATED MINI SCREW WAS IMPLANTED. APPROXIMATELY TWO WEEKS PRIOR TO FOLLOW UP PATIENT STARTED DEVELOPING PAIN. X-RAYS TAKEN NOTED HIS HARDWARE HAS BROKEN IN THE CAPITATE. OP REPORT (B)(6) 18: PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 DURING WHICH THE LUNATE-CAPITATE FUSION WAS ENCOUNTERED. IT WAS NOTED THIS WAS A PARTIAL FUSION. THE SCREW WAS IDENTIFIED AND REMOVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S PRODUCT. PART NUMBER OF THE SCREW THAT WAS EXPLANTED WAS AR-8730-24H, LOT 1299539.

  Patient problems: Pain

  MAUDE report 7285138 ↗