Arthrex® AR-4020C-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00888867276963), received between Feb 6, 2019 and Feb 20, 2026 — classified as 7 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Break” (81 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 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREWS 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 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 24402075 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREWS 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 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 24402065 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT DURING THE KNEE ARTHROSCOPY, 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 24376867 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT DURING A KNEE 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 24322574 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT DURING A KNEE 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 24322407 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT DURING THE RECONSTRUCTION OF THE CRUCIATE LIGAMENT, THE SCREW BROKE INTO SMALL PIECES. 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 24292886 ↗
• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY ONE SCREW BROKE IN THE FEMUR AND THE OTHER SCREW BROKE IN THE TIBIA. 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 24130410 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT DURING THE KNEE SURGERY, THE SCREW BROKE WHILE BEING SCREWED 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 SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. *** 28-NOV-2025 MAJUNG; FURTHER INFORMATION RECEIVED: THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829260 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREW BROKE. THE BROKEN PIECES WERE 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. UPDATE DW (B)(6) 2025: FURTHER INFORMATION WAS PROVIDED THAT THE FRAGMENT REMAINED INSIDE THE PATIENT AND WAS NOT RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23828389 ↗
• 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 23704795 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY THAT THE IMPLANT BROKE WHEN SCREWED INTO THE 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 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 23694094 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT 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 23427487 ↗
• MalfunctionOct 24, 2025Break; Break

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-4020C-08 07 X 20 MM FAST THREAD BIOCOMPOSITE VENTED INTERFERENCE SCREW BROKE. IT WAS NECESSARY TO USE ANOTHER 8X20 SCREW TO COMPLETE THE PATELLAR ACL PROCEDURE. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377657 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY A SCREW BREAKAGE OCCURRED WHEN STARTING TO INSERT THE DEVICE INTO THE FEMORAL TUNNEL. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23314088 ↗
• MalfunctionAug 11, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE DEVICE BROKE DURING SCREWING IN. ONE HALF OF THE DEVICE WAS LEFT IN THE PATIENT AND COULD NOT BE REMOVED. THE OTHER HALF OF THE DEVICE COULD BE REMOVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22777267 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE CORRECT SCREWDRIVER SHAFT AR-1996CD-1 (LOT: 47322444) WAS USED BUT THE DEVICE DID NOT LOCK COMPLETELY AT THE SCREWS AR-4020C-08 (LOT: 2X 15332832 AND 1X 15360168) AND THE 3 SCREWS BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DRIVER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

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

  MAUDE report 22567075 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE CORRECT SCREWDRIVER SHAFT AR-1996CD-1 (LOT: 47322444) WAS USED BUT THE DEVICE DID NOT LOCK COMPLETELY AT THE SCREWS AR-4020C-08 (LOT: 2X 15332832 AND 1X 15360168) AND THE 3 SCREWS BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DRIVER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

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

  MAUDE report 22567069 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE CORRECT SCREWDRIVER SHAFT AR-1996CD-1 (LOT: 47322444) WAS USED BUT THE DEVICE DID NOT LOCK COMPLETELY AT THE SCREWS AR-4020C-08 (LOT: 2X 15332832 AND 1X 15360168) AND THE 3 SCREWS BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DRIVER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

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

  MAUDE report 22567068 ↗
• 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 KPILZ 17-JUN-2025: FURTHER INFORMATION WAS RECEIVED THAT THERE WILL BE NO REVISION SURGERY. UPDATE KPILZ 16-JUN-2025: FURTHER INFORMATION WAS RECEIVED THAT SOME FRAGMENTS REMAINED INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22285000 ↗
• MalfunctionJun 16, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGERY WITH SEMITENDINOSUS AND GRACILIS STEMMED IT WAS TRIED TO INSTALL A FEMORAL SCREW AND THE DEVICE BROKE RIGHT AT THE BEGINNING. ALL FRAGMENTS WERE RETRIEVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (COMPETITOR¿S 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 22210398 ↗
• MalfunctionMay 2, 2025Crack; Crack

  ON 4/23/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-4020C-08 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW CRACKED DURING INSERTION INTO THE PATIENT'S LEFT KNEE. THE DOCTOR WAS INFORMED, ASSESSED THE SCREW FOR COMPLETENESS, AND REQUESTED A NEW SCREW. THIS WAS DISCOVERED DURING A PROCEDURE IN (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 4/30/2025:

  Patient problems: Insufficient Information

  MAUDE report 21952670 ↗
• InjuryMar 21, 2025Break; Break

  ON 3/7/2025, A FACILITY REPRESENTATIVE REPORTED VIA PHONE AND EMAIL THAT AN AR-4020C-08 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW 8 X 20 MM BROKE POSTOPERATIVELY IN A PATIENT AFTER A SOCCER INJURY, RESULTING IN ADDITIONAL SURGERY ON (B)(6) 2025. THE PATIENT HAD THE FIRST ACL PROCEDURE ON THE RIGHT KNEE ON (B)(6) 2024. TWO AR-4020C-08 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREWS WERE IMPLANTED SUCCESSFULLY, AND THE PATIENT HAD NO ISSUES AFTERWARD. BEGINNING OF (B)(6) 2025, THE PATIENT OBTAINED A SUBSEQUENT INJURY DURING A SOCCER GAME. X-RAYS WERE NOT TAKEN, BUT THE DOCTOR MADE A PHYSICAL DIAGNOSIS. A RIGHT KNEE ARTHROSCOPY LOOSE BODY EXCISION WAS PERFORMED ON (B)(6) 2025 FOR THE REMOVAL OF A POSTTRAUMATIC OSTEOCHONDRAL LOOSE BONE BODY ALONG WITH ONE 2X2 MM DISSOLVING IMPLANT FRAGMENT BROKEN OFF ONE AR-4020C-08 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW 8 X 20 MM. THE OTHER SCREW PARTS REMAINED INSIDE THE PATIENT. THE ADDITIONAL SURGERY WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS FINE TO DATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21663073 ↗
• MalfunctionJan 10, 2025Break; Break

  ON 12/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-4020C-08 BIOCOMPOSITE SCREW WOULD BREAK APART WHILE TIGHTENING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE WAS COMPLETED USING A DIFFERENT SCREW SIZE. ALL FRAGMENTS ABLE TO BE REMOVED. 15 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124518 ↗
• MalfunctionJan 10, 2025Break; Break

  ON 12/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-4020C-08 BIOCOMPOSITE SCREW WOULD BREAK APART WHILE TIGHTENING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE WAS COMPLETED USING A DIFFERENT SCREW SIZE. ALL FRAGMENTS ABLE TO BE REMOVED. 15 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124467 ↗
• MalfunctionJan 10, 2025Break; Break

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-4020C-08 BIOCOMPOSITE SCREW WOULD BREAK APART WHILE TIGHTENING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE WAS COMPLETED USING A DIFFERENT SCREW SIZE. ALL FRAGMENTS ABLE TO BE REMOVED. 20 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124428 ↗