AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 90mm 8065-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665022964), received between Sep 24, 2020 and Mar 7, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryMar 7, 2024Fracture; Fracture

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A 1310-040 ANTEGRADE FEMORAL NAIL HAD BEEN CRACKED INSIDE THE PATIENT AND WAS EXPERIENCING PAIN, WHICH WAS CONFIRMED BY AN X-RAY DONE ON THE PATIENT LAST WEEK. DURING THE ORIGINAL PROCEDURE OF AN ORIF LEFT FEMUR FRACTURE PROCEDURE ON (B)(6) 2023, A (1) 1310-040 ANTEGRADE FEMORAL NAIL/BATCH: 462737, (1) 8001-050 CAPTURED CORTICAL SCREW/BATCH: UNKNOWN / (1) 8001-055 CAPTURED CORTICAL SCREW/BATCH: UNKNOWN, (2) 8065-085 CANCELLOUS SCREW/BATCH: UNKNOWN AND BATCH: 472747, (1) 8065-090 CANCELLOUS SCREW/BATCH: 220505 ARTHREX PRODUCTS WERE IMPLANTED. THE ORIGINAL PROCEDURE HAD NO ISSUES REPORTED AND WAS COMPLETED SUCCESSFULLY. THE REMOVAL OF HARDWARE AND REPAIR OF THE LEFT FEMORAL ORIF FRACTURE REVISION PROCEDURE OCCURRED ON (B)(6) 2024. THE ARTHREX PRODUCTS THAT WERE EXPLANTED WERE (1) 1310-040 ANTEGRADE FEMORAL NAIL/BATCH: 462737, (1) 8001-050 CAPTURED CORTICAL SCREW/BATCH: UNKNOWN / (1) 8001-055 CAPTURED CORTICAL SCREW/BATCH: UNKNOWN, (2) 8065-085 CANCELLOUS SCREW/BATCH: UNKNOWN AND BATCH: 472747, (1) 8065-090 CANCELLOUS SCREW/BATCH: 220505. ADDITIONAL INFORMATION FOR THE ARTHREX PRODUCTS IMPLANTED DURING THE REVISI

  Patient problems: Pain

  MAUDE report 18857466 ↗
• InjurySep 24, 2020Fracture; Fracture

  ON (B)(6) 2020, AOS GOT REPORT THAT A PATIENT HAD BROKEN TWO SCREWS INSIDE THE PATIENT WITHIN THE ANTEGRADE FEMORAL NAIL. THERE WAS NO INFORMATION AVAILABLE FOR THE MECHANISM OF FAILURE FOR THE SCREWS. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2020. THE INITIAL SURGERY WAS TO CORRECT A PROXIMAL FEMORAL FRACTURE. IT WAS REPORTED THAT THE NAIL AND SCREW MAY HAVE BEEN USED FOR AN INTERTROCHANTERIC FRACTURE, BUT THERE ARE NO EVIDENCE TO SHOW THE INITIAL FRACTURE PATTERN OF THE SURGERY. MORE INFORMATION WAS REQUESTED TO SEE IF A REVISION SURGERY WAS SCHEDULED OR PLANNED.

  Patient problems: Failure of Implant

  MAUDE report 10582093 ↗