Arthrex® AR-8945-45FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867053748), received between Jun 26, 2019 and Sep 8, 2026 — classified as 1 injury, 1 malfunction.

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 16, 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.

• MalfunctionSep 8, 2026Fracture

  On 21-Aug-2026, it was reported by a sales representative via email that an AR-8945-45FT Fully Threaded Cannulated Low Profile Screw fractured when the screw head separated from the shaft while being implanted. The shaft remained in the bone. All loose fragments were removed from the patient. The procedure was completed successfully. This was discovered during an AMZ procedure performed on (b)(6) 2026.Additional information was received on 26-Aug-2026:The case was completed by implanting another screw. The replacement product used to complete the procedure was an AR-8945-50FT Fully Threaded Cannulated Low Profile Screw. There was no reported surgical delay; however, the surgeon redrilled and reinserted a screw. No additional anesthesia was administered to the patient.

  Patient problems: Insufficient Information

  MAUDE report 50670753 ↗
• InjuryJun 26, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A TIBIAL TUBERCLE OSTEOTOMY PROCEDURE, AS THE SURGEON WAS TIGHTENING THE AR-8945-45FT LOW PROFILE SCREW THE HEAD OF THE SCREW POPPED OFF. THE REP STATED THE THREADS OF THE SCREW WERE HOLDING FINE, JUST THE 2MM HEAD POPPED OFF. THE SCREW STAYED IMPLANTED AND THE BROKEN HEAD OF THE SCREW WAS RETRIEVED AS IT WAS NOT INSERTED INTO THE BONE. THE IMPLANT WAS SEATED AT A DEPTH OF 45MM. THE BONE QUALITY WAS HARD. THE CASE WAS COMPLETED AND AN UNPLANNED INCISION WAS NOT MADE. ADDITIONAL INFORMATION RECEIVED ON 06/12/2019: THE BONE WAS PREPPED WITH A 3.0 DRILL BIT. THE FULL LENGTH OF THE SCREW THREADS REMAINS IMPLANTED IN THE TIBIA. THE SCREW HELD AND THE SURGEON WAS HAPPY WITH THE FIXATION SO THERE WERE NOT ANY ATTEMPTS MADE TO REMOVE THE THREADED PORTION OF THE SCREW. A SECOND SCREW WAS NOT NEEDED, AND A GRAFT WAS NOT USED. THE BROKEN SCREW HEAD THAT WAS REMOVED WAS LOST AFTER BEING WASHED AND WILL NOT BE RETURNING.

  Patient problems: Foreign Body In Patient

  MAUDE report 8735075 ↗