Arthrex® AR-4020C-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00888867276949), received between Sep 10, 2020 and May 20, 2026 — classified as 2 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Break” (33 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Break

  IT WAS REPORTED THAT DURING A MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION SURGERY THE DEVICE BROKE DURING INSERTION. ALL BROKEN PARTS WERE RETRIEVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25229474 ↗
• MalfunctionMay 12, 2026Failure to Advance

  ON 24-APR-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-4020C-06 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW COULD NOT BE ADVANCED OVER THE NITINOL WIRE, AS RESISTANCE WAS ENCOUNTERED AND THE SCREW APPEARED TO HAVE MATERIAL OBSTRUCTING IT. THIS WAS DISCOVERED DURING AN MPFL PROCEDURE ON (B)(6) 2026.

  Patient problems: Insufficient Information

  MAUDE report 25150400 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT DURING THE KNEE SURGERY, THE SCREW BROKE INSIDE THE PATIENT´S KNEE AND A PART OF THE SCREW REMAINED IN THE PATIENT BECAUSE IT COULD NOT BE RETRIEVED. THE OTHER PART OF THE SCREW REMAINED ON THE SCREWDRIVER AND WAS REMOVED. 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: Foreign Body In Patient

  MAUDE report 24818207 ↗
• InjuryMar 18, 2026Break

  IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY, THE SCREW BROKE INSIDE THE PATIENT. 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 24626231 ↗
• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT DURING THE ARTHROSCOPY, THE IMPLANT BROKE WHILE BEING INSERTED. 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 05-MAR-2026 - FURTHER INFORMATION WAS RECEIVED: THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590997 ↗
• 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 24563120 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT DURING THE KNEE SURGERY, THE SCREW BROKE. 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 24376410 ↗
• MalfunctionJan 12, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREW BECAME STUCK DURING INSERTION FORCING THE SURGEON TO BREAK IT IN ORDER TO REMOVE THE SCREW. ALL FRAGMENTS WERE RETRIEVED. 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 24035482 ↗
• MalfunctionJan 12, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREW BECAME STUCK DURING INSERTION FORCING THE SURGEON TO BREAK IT IN ORDER TO REMOVE THE SCREW. ALL FRAGMENTS WERE RETRIEVED. 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 24035100 ↗
• MalfunctionJan 8, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREW BECAME STUCK DURING INSERTION FORCING THE SURGEON TO BREAK IT IN ORDER TO REMOVE THE SCREW. ALL FRAGMENTS WERE RETRIEVED. 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 24012357 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY THE DEVICE BROKE INTO PIECES WHEN IMPLANTED. NO FURTHER INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 24005464 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED DURING THE ARTHROSCOPY THAT THE IMPLANT HAD BROKEN APART WHEN 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 23694202 ↗
• MalfunctionNov 10, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE DEVICE WAS DEFORMED OR DEFORMED IN THE FACE, AS IT WAS TOO FLEXIBLE AND GOT TWISTED. 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: IT WAS CONFIRMED THAT DURING THE SAME SURGERY IN TOTAL 4 DEVICES FROM THE SAME BATCH FAILED. TWO DEVICES BROKE AND TWO GOT BENT. TWO SCREWS WERE THROWN AWAY AND THE OTHER TWO WERE SUCCESSFULLY INSERTED INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511234 ↗
• MalfunctionNov 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY, THE DEVICE WAS DEFORMED OR DEFORMED IN THE FACE, AS IT WAS TOO FLEXIBLE AND GOT TWISTED. 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) 24-OCT-2025: IT WAS CONFIRMED THAT DURING THE SAME SURGERY IN TOTAL 4 DEVICES FROM THE SAME BATCH FAILED. TWO DEVICES BROKE AND TWO GOT BENT. TWO SCREWS WERE THROWN AWAY AND THE OTHER TWO WERE SUCCESSFULLY INSERTED INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511230 ↗
• MalfunctionNov 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE DEVICE WAS DEFORMED OR DEFORMED IN THE FACE, AS IT WAS TOO FLEXIBLE AND GOT TWISTED. 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 AVOE 24-OCT-2025 IT WAS CONFIRMED THAT DURING THE SAME SURGERY IN TOTAL 4 DEVICES FROM THE SAME BATCH FAILED. TWO DEVICES BROKE AND TWO GOT BENT. TWO SCREWS WERE THROWN AWAY AND THE OTHER TWO WERE SUCCESSFULLY INSERTED INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511226 ↗
• MalfunctionOct 27, 2025Material Twisted/Bent; Material Twisted/Bent

  UPDATE AVOE 24-OCT-2025. IT WAS CONFIRMED THAT DURING THE SAME SURGERY IN TOTAL 4 DEVICES FROM THE SAME BATCH FAILED. TWO DEVICES BROKE AND TWO GOT BENT. TWO SCREWS WERE THROWN AWAY AND THE OTHER TWO WERE SUCCESSFULLY INSERTED INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391167 ↗
• MalfunctionJul 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE DEVICE SHEARED INTO PIECES DURING THE IMPLANTATION. 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 22610976 ↗
• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC 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.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414686 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE SCREW BROKE WHILE SCREWING. 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) 05-MAY-2025. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL FRAGMENTS OF THE BROKEN SCREW WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961144 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREW BROKE. NOTHING BROKE OFF INSIDE THE PATIENT. 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 21890684 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE IMPLANT BROKE DURING THE INSERTION. 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 21883317 ↗
• MalfunctionMar 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENTOPLASTY SURGERY THE SCREW BROKE. 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 21620578 ↗
• MalfunctionOct 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A LIGAMENTOPLASTY SURGERY THE SCREW DISLOCATED AT ITS UPPER PART. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 20397949 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE LIGAMENTOPLASTY SURGERY THE DEVICE BROKE INSIDE THE PATIENTS FEMUR. ALL PARTS WERE RETRIEVED FROM THE 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809695 ↗
• MalfunctionJul 1, 2024Break; Break

  ON 06/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4020C-06 FASTTHREAD¿ BIOCOMPOSITE¿ INTERFERENCE SCREWS TIP WAS IMMEDIATELY CHIPPED OFF UPON INITIAL INSERTION. THIS OCCURRED DURING A CASE AND DESPITE MULTIPLE ATTEMPTS TO CONTINUE TO INSERT THE SCREW, IT FAILED TO GO IN. THE PATIENT WAS NOT HARMED, AND WE COMPLETED THE CASE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644510 ↗