Arthrex® AR-4019DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867291928), received between Jan 11, 2022 and Apr 8, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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.

• MalfunctionApr 8, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE WIRE IS STUCK. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AHA 26-MAR-2024: THERE WAS A FOREIGN OBJECT IN THE TIP OF THE DEVICE. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060584 ↗
• MalfunctionJan 11, 2022Dull, Blunt

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY MULTIPLE SCREW DRIVERS WERE BLUNT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 26-OCT-2021 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE REPORTED EVENT OCCURRED DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR AND THE SCREWDRIVER WAS TWISTED AND NOT DULL. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225808 ↗