Arthrex® AR-4030C-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00888867277656), received between Dec 2, 2020 and Jun 22, 2026 — classified as 1 injury, 42 malfunctions.

The most frequently reported specific device problem is “Break” (40 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.

• MalfunctionJun 22, 2026Break

  IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY, THE SCREW (AR-4030C-08) BROKE OFF. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. FURTHERMORE, IT WAS REPORTED THAT DURING THE SAME SURGERY, THE SCREW (AR-4030C-09) WOULD NOT SEAT IN 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 25577697 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY THE TIP OF THE SCREW BROKE OF WHEN SCREWED IN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809288 ↗
• 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 24292604 ↗
• MalfunctionJan 28, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE WHILE THE GRAFT WAS FIXATED. 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 ANOTHER SCREW. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198417 ↗
• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE IMPLANT BROKE WHILE IT WAS SCREWED INTO THE BONE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23781492 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE BROKE TIBIALLY DURING SCREWING IN. ALL BROKEN PARTS 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 PART NUMBER AR-1588TB-4. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450063 ↗
• MalfunctionSep 15, 2025Break; Break

  ON 8/26/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4030C-08 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW BROKE DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER AR-4030C-08 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW. THIS WAS DISCOVERED DURING AN MPFL RECONSTRUCTION PROCEDURE. THE PATIENT WAS NOT AFFECTED. ADDITIONAL INFORMATION WAS RECEIVED ON 9/02/2025: THIS ISSUE OCCURRED DURING AN MPFL RECONSTRUCTION PROCEDURE PERFORMED ON (B)(6) 2025. THE ANCHOR WAS REMOVED FROM THE PATIENT WITHOUT CAUSING ANY DELAY TO THE CASE OR REQUIRING ADDITIONAL ANESTHESIA. NO PHOTOGRAPHIC DOCUMENTATION WAS TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23054289 ↗
• MalfunctionSep 15, 2025Break; Break

  ***UPDATE DW 21-OCT-2025: FURTHER INFORMATION WAS PROVIDED THAT THE INITIALLY ENTERED AWARENESS DATE WAS INCORRECT. THE FIRST ARTHREX EMPLOYEE WAS MADE AWARE OF THE ISSUE ON 11-SEP-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23053317 ↗
• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE APART 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 23009893 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT DURING ARTHROSCOPIC SUTURING OF THE MENISCUS THE SCREW BROKE DURING 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 22882530 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE DURING INSERTION. ALL 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 22872810 ↗
• MalfunctionJul 23, 2025Break; Break

  ON 06/30/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-4030C-08 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW BROKE IN HALF DURING INSERTION. ALL PIECES OF THE BROKEN SCREW WERE RETRIEVED AND THE CASE WAS COMPLETED BY UTILIZING A REPLACEMENT AR-4030C-08 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW. NO ADVERSE EFFECTS ON THE PATIENT OR PROCEDURE WERE REPORTED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 07/09/2025: THE ISSUE OCCURRED DURING AN MPFL PROCEDURE ON (B)(6) 2025. NO CASE DELAY OR ADDED ANESTHESIA WAS ADMINISTERED BECAUSE A REPLACEMENT DEVICE WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575637 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE SCREW 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400732 ↗
• MalfunctionFeb 7, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREW BROKE. ALL PARTS 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 21333354 ↗
• MalfunctionDec 10, 2024Break; Break

  ON 11/11/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-4030C-08 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW BROKE IN THE MIDDLE DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 11/15/2024: THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION SURGERY. ALL THE BROKEN FRAGMENTS WERE SUCCESSFULLY RETRIEVED. THE CASE WAS COMPLETED USING ANOTHER AR-4030C-08 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW. THE CASE WAS NOT DELAYED AS THE NEW SCREW WAS READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892125 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE OFF WHEN IMPLANTED. THE IMPLANTED PART REMAINED INSIDE THE PATIENT AND THE BROKEN PART WAS RETRIEVED. 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: Foreign Body In Patient

  MAUDE report 20600175 ↗
• MalfunctionOct 1, 2024Damaged Thread; Damaged Thread

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY WHILE SCREWING IN THE SCREW, THE THREAD WAS DAMAGED. 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 20343191 ↗
• MalfunctionAug 9, 2024Positioning Failure; Positioning Failure

  ON 07/31/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-4020C-08 BIO-COMPOSITE SCREW WOULD NOT HOLD FIXATION, SURGEON UPSIZED THE SCREW TO AR-4030C-08 AND SCREW WOULD NOT HOLD FIXATION. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE COMPLETED USING AR-4020C-09 SCREW TO COMPLETE FIXATION. DELAY IN CASE 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949733 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE. 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. UPDATE AVOE 17-JUN-2024: IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643835 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGERY A SCREW BROKE OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE DW 19-JUN-2024: FURTHER INFORMATION WAS PROVIDED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PLASTIC SURGERY THE TIP OF THE SCREW BROKE OFF WHEN THE SURGEON INSERTED IT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW 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 19638225 ↗
• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED THAT DURING ACL SURGERY THE SCREW DID BREAK DURING INSERTION. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM 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 RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19481380 ↗
• MalfunctionMay 14, 2024Break; Break

  ON 04/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4030C-08 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW BROKE DURING INSERTION. THE TIBIA WAS PREPPED, AND THE GRAFT WAS PASSED. THE FEMORAL SCREW WAS PLACED, AND USING A WIDE NOTCHER, NITINOL WIRE, AND A FAST THREAD TAP, THE SCREW WAS INSERTER. ABOUT HALFWAY DOWN, IT BROKE. THE BROKEN FRAGMENTS WERE REMOVED USING A RONGEUR. THE 8MM FAST THREAD TAP WAS REINTRODUCED AND TAPPED THE TUNNEL TWICE MORE, LEAVING THE TAP IN FOR 10 SECONDS. ANOTHER AR-4030C-08 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW WAS USED TO COMPLETE THE CASE. THE CASE WAS MINIMALLY DELAYED, AND THE PATIENT WAS NOT HARMED. THIS WAS DISCOVERED DURING AN AUTOGRAFT BTB ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19316216 ↗
• MalfunctionMay 13, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE FASTTHREAD SCREW WAS FOUND BENT INSIDE THE PACKAGING. IT WAS NOTICED BEFORE THE SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. ***UPDATE, KHE, 15-APR-2024: FURTHER INFORMATION RECEIVED AFTER A REQUEST. THE EVENT WAS NOTICED DURING A KNEE SURGERY. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO PIECE BROKE OFF INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NO. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. *** UPDATE DW 17-APR-2024: THE CUSTOMER REPORTED THAT THE ANCHOR WAS BENT AND COULD NOT BE INSERTED. HOWEVER AS THE DEVICE IS COVERED IN BLOOD IN CAN BE DETERMINED THAT THE CUSTOMER TRIED TO IMPLANT THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297865 ↗
• MalfunctionMay 9, 2024Break; Break

  ON 4/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4030C-08 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW BROKE DURING INSERTION. THE BROKEN FRAGMENTS WERE COMPLETELY REMOVED. AN AR-1380TC FULL THREAD CANNULATED BIOCOMPOSITE INTERFERENCE SCREW WAS THEN INSERTER, AND IT ALSO BROKE AT THE TOP. THE SURGEON, HOWEVER, WAS ABLE TO IMPLANT IT SUCCESSFULLY. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS DELAYED FIFTEEN MINUTES. THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280734 ↗
• MalfunctionFeb 29, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE SCREW TIP BROKE OFF INSIDE THE PATIENT AND IT WAS FOUND LOOSE IN THE KNEE JOINT. EVERYTHING WAS REMOVED 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18806335 ↗