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

Summary

The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 00888867276956), received between Jan 9, 2019 and Sep 9, 2026 — classified as 11 injuries, 130 malfunctions.

The most frequently reported specific device problem is “Break” (126 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 25 most recent of 141 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Break

  It was reported that during a knee surgery the biocomposite screw has broken into pieces while the surgeon was inserting it. There was no harm for patient, operator or third party reported. No further information received.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694155 ↗
• MalfunctionAug 28, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50502078 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY, THE SCREW BROKE WHILE BEING SCREWED INTO THE BONE TO SECURE THE GRAFT. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION WAS RECEIVED. UPDATE 21-APR-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING THE RECONSTRUCTION ANTERIOR CRUCIATE LIGAMENT, THE SCREW BROKE WHILE BEING SCREWED INTO THE BONE TO SECURE THE GRAFT. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027440 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY THE SCREW BROKE DURING THE INSERTION. THE BROKEN SCREW WAS REMOVED 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 24840004 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT DURING THE RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT, THE SCREW BROKE DURING THE FIXATION OF THE GRAFT IN THE TIBIA BONE. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830353 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY THE SCREW WAS DILATED WITH A TAP BEFORE IMPLANTATION, AS IS CONSISTENT WITH THE CORRECT TECHNIQUE FOR IMPLANTATION INTO HARD BONE, AND YET THE DEVICE BROKE INTO SMALL PIECES WHEN GENTLY SCREWED INTO THE BONE. 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 24567325 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY THE SCREWS AR-4020C-07 (LOT: 15392107) AND AR-4020C-06 (LOT: 15030789) WERE DILATED WITH A TAP BEFORE IMPLANTATION, AS IS CONSISTENT WITH THE CORRECT TECHNIQUE FOR IMPLANTATION INTO HARD BONE, AND YET THE DEVICES BROKE INTO SMALL PIECES WHEN GENTLY SCREWED INTO THE BONE. 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 24563121 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICES BROKE WHILE SCREWING IN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE PART NUMBER AR-4020C-08. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557510 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICES BROKE WHILE SCREWING IN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE PART NUMBER AR-4020C-08. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557440 ↗
• MalfunctionFeb 3, 2026Break

  ON 12-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4020C-07 BIOCOMPOSITE INTERFERENCE SCREW BROKE WHILE PUTTING THE SCREW IN. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. THE BROKEN SCREW WAS REMOVED, AND THE CASE WAS COMPLETED WITH ANOTHER SCREW. IT WAS REPORTED THAT STANDARD PROCEDURE OR TECHNIQUE FOR IMPLANTATION WAS FOLLOWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24244965 ↗
• MalfunctionDec 22, 2025Break; Break

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-4020C-07 07 X 20 MM FAST THREAD BIOCOMPOSITE VENTED INTERFERENCE SCREW BROKE WHILE PERFORMING THE LATERAL REINFORCEMENT AFTER DRILLING THE FEMUR WITH A 6 MM DRILL TO FIX THE 5 MM ANTEROLATERAL GRAFT. WHEN TIGHTENING THE 07X20 SCREW, IT BROKE. ANOTHER SCREW WAS INSERTED, BUT IT ALSO FAILED, LIKELY DUE TO THE PATIENT¿S BONE QUALITY, WHICH WAS VERY HARD. THE ACL SCREW/SCREW MENISCUS REPAIR WITH PROTECTOR AND ANTEROLATERAL FIXATION WITH SCREW WAS COMPLETED BY SECURING WITH A KNOT. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864835 ↗
• MalfunctionDec 22, 2025Break; Break

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-4020C-07 07 X 20 MM FAST THREAD BIOCOMPOSITE VENTED INTERFERENCE SCREW BROKE WHILE PERFORMING THE LATERAL REINFORCEMENT AFTER DRILLING THE FEMUR WITH A 6 MM DRILL TO FIX THE 5 MM ANTEROLATERAL GRAFT. WHEN TIGHTENING THE 07X20 SCREW, IT BROKE. ANOTHER SCREW WAS INSERTED, BUT IT ALSO FAILED, LIKELY DUE TO THE PATIENT¿S BONE QUALITY, WHICH WAS VERY HARD. THE ACL SCREW/SCREW MENISCUS REPAIR WITH PROTECTOR AND ANTEROLATERAL FIXATION WITH SCREW WAS COMPLETED BY SECURING WITH A KNOT. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864707 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE WHILE BEING SCREWED IN. THE BROKEN PIECES WERE RETRIEVED FROM 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 23704813 ↗
• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE SCREW BROKE DURING INSERTION. ALL FRAGMENTS WERE RETRIEVED FROM 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 23630322 ↗
• MalfunctionNov 4, 2025Fracture; Fracture

  ON 10/27/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-4020C-07 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW 7 X 20 MM FRACTURED DURING PLACEMENT. THE HTH TECHNIQUE WAS PERFORMED, AND DURING FEMORAL FIXATION, THE SURGEON USED A NOTCHER FOLLOWED BY A 7 MM FASTTHREAD TAP BEFORE SCREW INSERTION. TOWARD THE END OF SCREW PLACEMENT, IT WAS OBSERVED THAT THE SCREW COULD NO LONGER BE ADVANCED. UPON ATTEMPTING REMOVAL, THE SCREW WAS FOUND TO HAVE FRACTURED AT THE HEAD, PREVENTING IT FROM ENTIRELY THREADING INTO THE BONE. LOOSE FRAGMENTS WERE SUCCESSFULLY RETRIEVED. NO ADDITIONAL ANESTHESIA WAS REQUIRED, AND NO ALTERNATIVE IMPLANT WAS USED. THIS ISSUE OCCURRED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/30/2025.

  Patient problems: Insufficient Information

  MAUDE report 23465373 ↗
• MalfunctionOct 30, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4020C-07 VENTED SCREW TIP BROKE OFF. THIS WAS DISCOVERED DURING A DISTAL BICEPS REPAIR PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER SCREW OF THE SAME PART NUMBER WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425342 ↗
• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY A PIECE OF THE SCREW BROKE WHILE INSERTION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY AND THE SCREW REMAINED INSIDE THE PATIENT. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095096 ↗
• MalfunctionSep 15, 2025Break; Break

  ON (B)(6) 2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT (QTY. 3) AR-4020C-07 07 X 20 MM FAST THREAD BIOCOMPOSITE VENTED INTERFERENCE SCREWS WERE BROKEN. THE FIRST SCREW BROKE DURING INSERTION. TWO ADDITIONAL SCREWS FROM THE SAME LOT ALSO FAILED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION ON A PATIENT'S LEFT KNEE. PER THE UOR REPORT, THE FRAGMENTS WERE REMOVED AND SEQUESTERED FOR ANALYSIS. A METAL SCREW WAS SUCCESSFULLY USED ON THE FOURTH ATTEMPT, AND THE PATIENT WAS TRANSFERRED TO PACU WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051402 ↗
• MalfunctionSep 15, 2025Break; Break

  ON 08/21/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT (QTY. 3) AR-4020C-07 07 X 20 MM FAST THREAD BIOCOMPOSITE VENTED INTERFERENCE SCREWS WERE BROKEN. THE FIRST SCREW BROKE DURING INSERTION. TWO ADDITIONAL SCREWS FROM THE SAME LOT ALSO FAILED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION ON A PATIENT'S LEFT KNEE. PER THE UOR REPORT, THE FRAGMENTS WERE REMOVED AND SEQUESTERED FOR ANALYSIS. A METAL SCREW WAS SUCCESSFULLY USED ON THE FOURTH ATTEMPT, AND THE PATIENT WAS TRANSFERRED TO PACU WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051401 ↗
• MalfunctionSep 15, 2025Break; Break

  ON 08/21/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT (QTY. 3) AR-4020C-07 07 X 20 MM FAST THREAD BIOCOMPOSITE VENTED INTERFERENCE SCREWS WERE BROKEN. THE FIRST SCREW BROKE DURING INSERTION. TWO ADDITIONAL SCREWS FROM THE SAME LOT ALSO FAILED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION ON A PATIENT'S LEFT KNEE. PER THE UOR REPORT, THE FRAGMENTS WERE REMOVED AND SEQUESTERED FOR ANALYSIS. A METAL SCREW WAS SUCCESSFULLY USED ON THE FOURTH ATTEMPT, AND THE PATIENT WAS TRANSFERRED TO PACU WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051400 ↗
• MalfunctionAug 22, 2025Break; Break

  ADDITIONAL INFORMATION WAS PROVIDED ON 09/26/2025 WHERE IT WAS REPORTED THAT THIS EVENT OCCURRED DURING AN ANKLE ARTHROSCOPY AND TENDON TRANSPORTATION ON (B)(6) 2025. AT THE TIME OF INSERTION INSIDE THE TUNNEL, THE DEVICE BROKE. AN INSTRUMENT WAS USED TO PREPARE THE BONE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ANOTHER AR-4020C-07 WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872287 ↗
• MalfunctionJul 30, 2025Break; Break

  ON 07/07/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-4020C-07 FASTTHREAD¿ BIOCOMPOSITE¿ INTERFERENCE SCREWS TIP BROKE OFF. THIS OCCURRED DURING A CASE.

  Patient problems: Insufficient Information

  MAUDE report 22663709 ↗
• MalfunctionJul 17, 2025Break; Break

  ON 06/23/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT (QTY. 2) OF AN AR-4020C-07 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW 7 X 20 MM BROKE PARTWAY THROUGH INSERTION DURING FEMORAL FIXATION, DESPITE THE USE OF STANDARD INSERTION TECHNIQUE. IN RESPONSE, THE SURGEON REAMED A SLIGHTLY LARGER TUNNEL, AND A THIRD AR-4020C-07 SCREW WAS SUCCESSFULLY IMPLANTED. THIS WAS DISCOVERED DURING AN MPFL PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535063 ↗
• MalfunctionJul 17, 2025Break; Break

  ON 06/23/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT (QTY. 2) OF AN AR-4020C-07 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW 7 X 20 MM BROKE PARTWAY THROUGH INSERTION DURING FEMORAL FIXATION, DESPITE THE USE OF STANDARD INSERTION TECHNIQUE. IN RESPONSE, THE SURGEON REAMED A SLIGHTLY LARGER TUNNEL, AND A THIRD AR-4020C-07 SCREW WAS SUCCESSFULLY IMPLANTED. THIS WAS DISCOVERED DURING AN MPFL PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 06/30/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535061 ↗
• MalfunctionJun 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE DEVICE BROKE. 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. ***UPDATE (B)(6) 2025: FURTHER INFORMATION WAS RECEIVED THAT THERE WILL BE NO REVISION SURGERY. ***UPDATE (B)(6) 2025: FURTHER INFORMATION WAS RECEIVED THAT SOME FRAGMENTS REMAINED INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22284612 ↗