Arthrex® AR-3375-4001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867030381), received between Jun 7, 2021 and Jul 18, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionJul 18, 2022Break

  CASE (B)(6) ON (B)(6) 2022 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3373-4002 OBTURATOR SNAP IN HALF DURING USE, THE WASHER CAME OUT. THIS WAS DISCOVERED DURING USE IN A PROCEDURE, WITH NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION 04/25/2022: ON (B)(6) 2022 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-3373-4002 OBTURATOR SNAP IN HALF AND THE WASHER CAME OUT, DURING USE IN A KNEE PROCEDURE AT (B)(6). THE CASE WAS COMPLETED USING A BACKUP SET. REQUESTED ADDITIONAL INFORMATION ON THE REMOVAL OF BROKEN FRAGMENTS FROM THE PATIENT. ADDITIONAL INFORMATION 04/28/2022: ON (B)(6) 2022 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-3373-4002 OBTURATOR SNAP IN HALF AND THE WASHER CAME OUT, DURING USE IN A KNEE PROCEDURE AT (B)(6). NOTHING WAS LEFT IN THE PATIENT ALL FRAGMENT WILL BE RETURNED. THE CASE WAS COMPLETED USING A BACKUP SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041083 ↗
• MalfunctionMay 23, 2022Break

  IT WAS REPORTED THAT THE CONICAL OBTURATOR IS BROKEN OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. UPDATE ON (B)(6) 2022: IT WAS CONFIRMED THAT THE DEVICE BROKE DURING A SURGERY DURING INSERTION. THE BREAKAGE POINT WAS OUTSIDE OF THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469606 ↗
• MalfunctionJun 7, 2021Break

  IT WAS REPORTED THAT THE DEVICE BROKE OFF. UPDATE 18-MAY-2021: THE GUIDE ROD BROKE OFF WHEN ENTERING THE SUBACROMINAL SPACE. THE BREAKAGE POINT WAS OUTSIDE THE PATIENT. NOTHING NEEDED TO BE REMOVED FROM THE PATIENT. NOBODY WAS HARMED. A SHOULDER ARTHROSCOPY WAS PERFORMED, IT WAS FINISHED SUCCESSFULLY. THE TECHNIQUE WAS NOT CHANGED AND A SECOND SURGERY WAS NOT NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11947804 ↗