Arthrex® AR-4020P-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867295032), received between Jul 27, 2026 and Jul 27, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryJul 27, 2026Patient Device Interaction Problem

  It was reported by a patient, through review of medical records, that on (b)(6)2025, the patient underwent ACL reconstruction. The operative report indicates the following Arthrex products were used for the procedure: AR-4580R FiberStitch (Lot Unknown), AR-4580S FiberStitch (Lot 25C05) AR-1588AL-CP2 Allograft GraftLink Implant System (Lot 15317362); AR-4580 FiberStitch (Lot 25D03), AR-4020-C-09 FastThread BioComposite Interference Screw, 9 x 20 mm (Lot 15454391) and AR-4020C-09 and AR-4020P-10 FastThread PEEK Interference Screw 10 mm × 20 mm (Lot 15231522A). Patient medical records support implantation of the AR-4020C-09 and AR-4020P-10 interference screws. Information provided by the patient alleges an AR-4030C-10 BioComposite Interference Screw, 10 x 30 mm may have been used and fractured during implantation; however, no such event is documented in the November 24, 2025 operative report. The exact intraoperative sequence, device utilization, and circumstances surrounding the alleged fracture of a device could not be conclusively determined from the available records. Following a reported traumatic event at home where the patient's left knee was hyperextended and twisted, the pati

  Patient problems: Failure of Implant

  MAUDE report 50006505 ↗
• InjuryJul 27, 2026Patient Device Interaction Problem

  It was reported by a patient, through review of medical records, that on (b)(6) 2025, the patient underwent ACL reconstruction. The operative report indicates the following Arthrex products were used for the procedure: AR-4580R FiberStitch (Lot Unknown), AR-4580S FiberStitch (Lot 25C05) AR-1588AL-CP2 Allograft GraftLink Implant System (Lot 15317362); AR-4580 FiberStitch (Lot 25D03), AR-4020-C-09 FastThread BioComposite Interference Screw, 9 x 20 mm (Lot 15454391) and AR-4020C-09 and AR-4020P-10 FastThread PEEK Interference Screw 10 mm × 20 mm (Lot 15231522A). Patient medical records support implantation of the AR-4020C-09 and AR-4020P-10 interference screws. Information provided by the patient alleges an AR-4030C-10 BioComposite Interference Screw, 10 x 30 mm may have been used and fractured during implantation; however, no such event is documented in the November 24, 2025 operative report. The exact intraoperative sequence, device utilization, and circumstances surrounding the alleged fracture of a device could not be conclusively determined from the available records. Following a reported traumatic event at home where the patient's left knee was hyperextended and twisted, the pat

  Patient problems: Failure of Implant

  MAUDE report 50006503 ↗
• InjuryJul 27, 2026Break

  It was reported by a patient, through review of medical records, that on (b)(6)2025, the patient underwent ACL reconstruction. The operative report indicates the following Arthrex products were used for the procedure: AR-4580R Fiber Stitch (Lot Unknown), AR-4580S Fiber Stitch (Lot 25C05) AR-1588AL-CP2 Allograft Graft Link Implant System (Lot 15317362); AR-4580 Fiber Stitch (Lot 25D03), AR-4020-C-09 Fast Thread Bio Composite Interference Screw, 9 x 20 mm (Lot 15454391) and AR-4020C-09 and AR-4020P-10 Fast Thread PEEK Interference Screw 10 mm × 20 mm (Lot 15231522A). Patient medical records support implantation of the AR-4020C-09 and AR-4020P-10 interference screws. Information provided by the patient alleges an AR-4030C-10 Bio Composite Interference Screw, 10 x 30 mm may have been used and fractured during implantation; however, no such event is documented in the November 24, 2025 operative report. The exact intraoperative sequence, device utilization, and circumstances surrounding the alleged fracture of a device could not be conclusively determined from the available records. Following a reported traumatic event at home where the patient's left knee was hyperextended and twisted,

  Patient problems: Failure of Implant

  MAUDE report 50000865 ↗