Arthrex® AR-4030P-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867295063), received between Nov 25, 2025 and Sep 21, 2026 — classified as 3 malfunctions.

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

• MalfunctionSep 21, 2026Use of Device Problem

  It was reported that during a surgery that the screws are not providing sufficient fixation. As a result, instead of using two screws as initially planned, they are sometimes required to use additional screws or a larger size to finish the surgery successfully. Per complaint reporter there was no harm for patient, operator or third party. It was not necessary to switch the surgical technique or do a second surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838604 ↗
• MalfunctionMar 13, 2026Positioning Failure

  IT WAS REPORTED THAT DURING THE ARTHROSCOPIC STABILIZATION OF THE GRAFT IN THE TIBIAL TUNNEL, THE SECURING SUTURE BROKE, NECESSITATING THE USE OF ANOTHER IMPLANT. THE SURGEON DECIDED TO CHANGE THE METHOD OF GRAFT FIXATION, TO A 9X30 PEEK SCREW WHICH WAS USED ACCORDING TO THE TECHNIQUE (TIBIAL TUNNEL WIDTH 9.5MM), BUT THE SCREW WAS SEATED TOO LOOSELY IN THE TUNNEL, REQUIRING THE USE OF A DIFFERENT IMPLANT TO FINISH THE SURGERY SUCCESSFULLY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597439 ↗
• MalfunctionNov 25, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION THE SCREW DID NOT HOLD IN THE DRILL CHANNEL. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-4030P-10). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647518 ↗