Arthrex® AR-4030C-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00888867277649), received between May 3, 2021 and Apr 6, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY, THE SCREW BROKE INTO SEVERAL PIECES WHILE BEING SCREWED INTO THE BONE WITH 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 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 24788473 ↗
• MalfunctionFeb 13, 2026Break

  ON 27TH JAN 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-4030C-07, FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW 7 X 30 MM, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A KNEE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4030C-07. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331658 ↗
• MalfunctionDec 9, 2025Break; Break

  IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION THE SCREW BROKE. THE SCREW COULD NOT BE COMPLETELY REMOVED FROM THE PATIENT. ONLY THE PART PROTRUDING FROM THE BONE COULD BE REMOVED. A SWIVELOCK ANCHOR WAS USED FOR ADDITIONAL FIXATION. 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. FURTHER INFORMATION WAS RECEIVED: THE SCREW ALSO BROKE INTO SMALL PIECES. THE REPORTED ECG CHANGES IN THE MHRA USER REPORT WERE AN ERROR. THE PATIENT HAD NO CLINICAL SYMPTOMS OR EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759992 ↗
• MalfunctionDec 9, 2025Break; Break

  IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION THE SCREW BROKE. THE SCREW COULD BE COMPLETELY REMOVED 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. FURTHER INFORMATION WAS RECEIVED: THE SCREW ALSO BROKE INTO SMALL PIECES. THE REPORTED ECG CHANGES IN THE MHRA USER REPORT WERE AN ERROR. THE PATIENT HAD NO CLINICAL SYMPTOMS OR EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759909 ↗
• MalfunctionSep 19, 2025Positioning Failure; Positioning Failure

  ON 1ST SEP 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-4030C-07, FASTTHREAD¿ BIOCOMPOSITE¿ INTERFERENCE SCREW 7 X 30 MM, THE ANCHOR COULD NOT BE INSERTED. THIS WAS DETECTED DURING A KNEE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4030C-07. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094851 ↗
• 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 22882505 ↗
• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A TIBIAL FIXATION IN AN ANTERIOR CRUCIATE LIGAMENT SURGERY WHEN THE DEVICE WAS INSERTED INTO THE TUNNEL, THE SCREW BROKE INTO MANY SMALL PIECES. 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 21909816 ↗
• MalfunctionFeb 12, 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 21364862 ↗
• MalfunctionOct 24, 2024Break; Break

  ON 10/18/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-4030C-07 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW AND AR-4020C-07 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW BROKE DURING INSERTION. THE CASE WAS COMPLETED USING A PRODUCT FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING A MULTILIGAMENT ACL PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20524335 ↗
• MalfunctionSep 25, 2024Break; Break

  ON 19 SEPTEMBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT 2 X AR-4030C-07 Ø7X 30MM BC IF SCRW, VENTED WERE REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON (B)(6) 2024 IN THE AVENUE PRIVATE HOSPITAL DURING AN MPFL REVISION. IT WAS REPORTED THAT THE FAST THREAD SCREW IMPLANTS FAILED DURING IMPLANTATION - IMPLANTS SNAPPED WHEN SCREWING INTO FEMUR. THE CASE WAS COMPLETED SUCCESSFULLY USING A USED A BIOCOMPOSITE SCREW INSTEAD OF FAST THREAD. THERE WAS CASE INVOLVEMENT.

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

  MAUDE report 20302194 ↗
• MalfunctionSep 25, 2024Break; Defective Device; Break; Defective Device

  ON 19 SEPTEMBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT 2 X AR-4030C-07 Ø7X 30MM BC IF SCRW, VENTED WERE REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON 18 SEPTEMBER 2024 IN THE (B)(6) HOSPITAL DURING AN MPFL REVISION. IT WAS REPORTED THAT THE FAST THREAD SCREW IMPLANTS FAILED DURING IMPLANTATION - IMPLANTS SNAPPED WHEN SCREWING INTO FEMUR. THE CASE WAS COMPLETED SUCCESSFULLY USING A USED A BIOCOMPOSITE SCREW INSTEAD OF FAST THREAD. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20300257 ↗
• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION AND LATERAL TENODISIS SURGERY THE SCREW DID NOT FIT ON THE SCREWDRIVER AND WHEN INSERTING THE DEVICE, THE SCREW BROKE INSIDE THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE PART NUMBER AR-2324PSLC. THE SURGEON SWITCHED THE SURGICAL TECHNIQUE. HE DID THE FIXATION WITH A SUTURE ANCHOR, PEEK SWIVELOCK. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20017123 ↗
• MalfunctionFeb 28, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE SCREW TIP TURNED OFF AT THE TOP OF THE SCREW. THE SCREW WAS LEFT IN THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE BROKEN SCREW. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18804308 ↗
• MalfunctionDec 15, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW AR-4030C-07 BROKE OFF INSIDE THE PATIENT. THEN THE SURGEON USED AN AR-4020C-07, WHICH ALSO BROKE OFF. THEN A NEW AR-4030C-07 WAS USED AND WAS SUCCESSFULLY USED TO FINISH THE SURGERY. 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. UPDATE SWIT 17-NOV-2023: THE SCREW BROKE WHEN IT WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340856 ↗
• MalfunctionOct 10, 2023Break; Break

  IT WAS REPORTED THAT DURING A TIBIAL CRUCIATE LIGAMENT FIXATION SURGERY THE SCREW BROKE OFF DURING SCREWING IN. 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: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908428 ↗
• MalfunctionAug 2, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW FRACTURED WHILE BEING INSERTED. 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 (B)(6) 2023. IT WAS CONFIRMED THAT NO BROKEN PARTS REMAINED INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17445925 ↗
• MalfunctionJun 7, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE IMPLANT BROKE OFF WHEN IT WAS INSERTED. THE BROKEN PIECES WERE RETRIEVED OUT OF 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.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078255 ↗
• MalfunctionJan 30, 2023Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE DURING INSERTION. 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: Foreign Body In Patient

  MAUDE report 16263648 ↗
• MalfunctionDec 27, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW SCREWS. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 12-DEC-2022: THE SCREWS BROKE OFF INSIDE THE PATIENT. ALL BROKEN PIECES COULD BE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NEW SCREWS FROM THE SAME MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051752 ↗
• MalfunctionMay 31, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE BROKE DURING INSERTION. ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT. 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 14547288 ↗
• MalfunctionApr 4, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE BROKE OFF INTRAOPERATIVELY. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. 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 13995330 ↗
• MalfunctionMar 28, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT QTY. 2 OF AN AR-4030C-08 FASTTHREAD¿ BIOCOMPOSITE¿ INTERFERENCE SCREW 8 X 30 MM AND AN AR-4030C-07 FASTTHREAD¿ BIOCOMPOSITE¿ INTERFERENCE SCREW 7 X 30 MM HAD AN ISSUE. A SURGEON BROKE THESE 3 TIBIAL SCREWS, TRYING TO INSERT THEM FOR AN ACL FIXATION ON (B)(6) 2022. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA EMAIL AND PHONE: A TIBIAL DRILL BIT WAS USED TO PREPARE THE BONE SOCKET FOR INSERTION OF THE IMPLANTS, THE BONE QUALITY OF THE PATIENT WAS NOT PROVIDED. PIECES OF THE IMPLANTS BROKE OFF INSIDE THE PATIENT AND ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED BY USING ONE METAL INTERFERENCE SCREW INSTEAD, PART AND LOT NUMBER WERE UNKNOWN. THIS PROLONGED THE SURGERY BY ABOUT 20 MINUTES, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED AND THE CASE WAS COMPLETED SUCCESSFULLY. THE OUTCOME SEEMED TO BE FINE, NO PATIENT HARM, BUT THE PATIENT WILL HAVE ONE METAL SCREW INSTEAD OF THREE ABSORBABLE ONES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929267 ↗
• MalfunctionNov 8, 2021Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE WHILE IMPLANTING IT. THE SURGEON REPORTED THAT 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 12770742 ↗
• MalfunctionNov 8, 2021Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE BROKE WHEN IMPLANTING THE DEVICE. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 12770509 ↗
• MalfunctionOct 19, 2021Break

  IT WAS REPORTED THAT DURING ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREWS BROKE OFF DURING SURGERY. THE BROKEN OFF PIECES HAVE BEEN RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A SCREW FROM ANOTHER MANUFACTURER. 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 12659831 ↗