Arthrex® AR-4030C-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867277687), received between Mar 22, 2023 and Jul 28, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE IMPLANT BROKE DURING INSERTION. THE BROKEN PIECE WAS RETRIEVED OUT OF THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637941 ↗
• MalfunctionJun 18, 2024Damaged Thread; Damaged Thread

  IT WAS REPORTED THAT DURING ACL SURGERY THE SCREW THREAD IS FAULTY AND CANNOT BE SCREWED IN. THERE WAS NO HARM OR ADVERSE EVENT 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. NO FURTHER INFORMATION RECEIVED. UPDATE, 23-MAR-2021 -SAC RECEIVED FURTHER INFORMATION THAT DURING SURGERY THE SCREW HAS BEEN TRIED TO SCREW IN BEFORE BUT DID NOT WORK. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558981 ↗
• MalfunctionJun 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 3/9/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4030C-11 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW GOT STUCK TO A SCREWDRIVER AND PULLED OUT WHEN THE DRIVER WAS BEING REMOVED. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2023. A NEW AR-4030C-11 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW WAS USED TO COMPLETE THE CASE. ADDITIONAL INFORMATION RECEIVED ON 3/13/2023: WHEN THE SURGEON REMOVED THE SCREWDRIVER FROM INSIDE THE PATIENT AND THE SCREW PULLED OUT, THE SURGEON HAD TO BREAK UP THE SCREW TO REMOVE IT FROM THE DRIVER ENTIRELY. NOTHING BROKE INSIDE THE PATIENT AS THE SURGEON BROKE THE SCREW AFTER IT WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495263 ↗
• MalfunctionMay 17, 2024Break; Break

  ON 4/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT TWO AR-4030C-11 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREWS BROKE DURING INSERTION. WITH THE FIRST SCREW, THE SURGEON DID NOT USE A TAP. WITH THE SECOND SCREW, A TAP WAS USED, BUT THE ANCHOR STILL BROKE. THE PATIENT HAD HARD BONE. ALL THE BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS NOT DELAYED. A THIRD AR-4030C-11 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW, FROM ANOTHER LOT NUMBER, WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19343561 ↗
• MalfunctionMay 17, 2024Break; Break

  ON 4/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT TWO AR-4030C-11 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREWS BROKE DURING INSERTION. WITH THE FIRST SCREW, THE SURGEON DID NOT USE A TAP. WITH THE SECOND SCREW, A TAP WAS USED, BUT THE ANCHOR STILL BROKE. THE PATIENT HAD HARD BONE. ALL THE BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS NOT DELAYED. A THIRD AR-4030C-11 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW, FROM ANOTHER LOT NUMBER, WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19343512 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE SURGERY THE ANCHOR BROKE INSIDE THE PATIENT DURING INSERTION. IT WAS POSSIBLE TO RETRIEVE THE BROKEN PIECES FROM THE PATIENT. 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. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011521 ↗
• MalfunctionMar 22, 2023Break; Break

  IT WAS REPORTED THAT DURING A PRIMARY ACL RECONSTRUCTION PROCEDURE THE SCREW BROKE INSIDE THE TIBIAL TUNNEL DUE TO NOT ENGAGING THE SCREWDRIVER. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16589706 ↗