Arthrex® AR-4020P-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867295001), received between Feb 7, 2022 and Apr 17, 2025 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionApr 17, 2025Break; Break

  ON 04/01/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(6) THAT AN AR-4020P-07 FASTTHREAD¿ PEEK INTERFERENCE SCREW WITH DISPOSABLE SHEATH BROKE. THIS OCCURED DURING A CASE WHEN THE SURGEON MOUNTED THE SCREW ON THE SCREWDRIVER AND WHEN HE TRIED TO PLACE IT IN THE PATIENT, IT BROKE.

  Patient problems: Insufficient Information

  MAUDE report 21861515 ↗
• InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 3/21/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY NURSE REPORTED THAT AN AR-4020P-07 FASTTHREAD PEEK INTERFERENCE SCREW WAS NOT AN ADEQUATE FIT. AS THE SURGEON REMOVED THE SCREWDRIVER, IT WAS NOTICED THE PEEK SCREW WAS NOT AT THE END OF THE SCREWDRIVER. THE SURGICAL SITE AS WELL AS THE SURROUNDING AREAS WERE SEARCHED FOR THE SCREW BUT COULD NOT BE LOCATED. AN X-RAY WAS TAKEN USING FLUOROSCOPY AND THE SCREW COULD STILL NOT BE LOCATED. AN MRI WAS TAKEN POST-OPERATIVE WHICH REVEALED A PLASTIC SCREW IN THE PATIENT'S PATELLAR POUCH. THIS OCCURRED DURING A PATELLAR LIGAMENT REPAIR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 3/25/2024: ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY AND HAD THE RETAINED FOREIGN OBJECT REMOVED. NO KNOWN HARM TO THE PATIENT DURING OR AFTER THESE PROCEDURES WERE COMPLETED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDE. ADDITIONAL INFORMATION RECEIVED ON 3/26/2024: THE REVISION SURGERY TOOK PLACE ON (B)(6) 2024, AND THE FASTTHREAD PEEK INTERFERENCE SCREW WAS SUCCESSFULLY REMOVED FROM INSIDE THE PATIENT. NO OTHER ARTHREX PRODUCTS WERE EXPLANTED AND NO NEW PRODUCTS WERE IMPLANTED. THE PROCEDURE WAS PERFORMED TO O

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 19116689 ↗
• MalfunctionFeb 7, 2022Break

  ON (B)(6) 2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT A AR-4020P-07 FASTTHREAD BROKE. THIS OCCURRED ON 11/23/2021 DURING A BTB AUTOGRAFT ACL RECONSTRUCTION. ONCE THE GRAFT PASSED THE PENCIL DILATOR WAS USED AND THEN THE PEEK FAST THREAD SCREW WAS BROUGHT IN. THE SCREW BROKE IN HALF WHILE BEING SCREWED IN. ALL BROKEN FRAGMENTS WERE RETRIEVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A AR-1370E. THE PATIENT HAD HARD BONE QUALITY. THERE WAS NO EFFECT TO THE PATIENT REPORTED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 11/24/2021 : THE BONE WAS PREPPED USING 2.4 PIN FROM AR-1898S, FOLLOWED BY 1409LP, THEN AR-1845 NOTCHER, AFTER GRAFT PASSED 1.1 NITINOL WIRE PLACED AR-1377C-07 DILATOR USED THEN SCREW PLACED OVER NITINOL WIRE.

  Patient problems: Insufficient Information

  MAUDE report 13471083 ↗