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Arthrex® AR-8724-08Recalls & reported problems

Arthrex, Inc. · LOW PROFILE SCREW, 2.4 X 8MM, CORTEX · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867045057), received between Dec 2, 2020 and Dec 2, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Advance” (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

Device problems

  • Difficult to Advance1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 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: Insufficient Information

    MAUDE report 10934536 ↗

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Sources and updates

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