Arthrex® AR-4030C-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00888867277670), received between Jun 26, 2019 and Mar 16, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Break

  IT WAS REPORTED THAT DURING THE COLLATERAL LIGAMENT RECONSTRUCTION, THE TIP OF THE SCREW BROKE OFF DURING INSERTION. THE BROKEN PIECE WAS 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 24608457 ↗
• MalfunctionJan 23, 2026Fracture

  ON 12-JAN-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED THAT AN AR-4030C-10 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW (10 × 30 MM) FRACTURED IN HALF DURING TIBIAL FIXATION IN AN ACL RECONSTRUCTION PERFORMED ON (B)(6) 2026. THE GRAFT WAS PREPARED WITH SUPERSUTURES AND MEASURED 8.5 MM IN DIAMETER. THE TIBIAL TUNNEL WAS CREATED USING AN 8 MM DRILL BIT AND SUBSEQUENTLY DILATED TO 8.5 MM. DURING INSERTION OF THE 10 × 30 MM INTERFERENCE SCREW, THE SURGEON NOTED INCREASED RESISTANCE, AND THE SCREW FRACTURED. AN ATTEMPT TO RETRIEVE THE TIP OF THE SCREW FRAGMENT WAS UNSUCCESSFUL. THE SURGEON ASSESSED KNEE STABILITY INTRAOPERATIVELY AND COMPLETED FIXATION USING A NON-ARTHREX 4.5 MM CORTICAL SCREW POST. ADDITIONAL INFORMATION WAS REQUESTED ON 14-JAN-2026.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 24164277 ↗
• MalfunctionOct 17, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 10/20/2025: THIS ISSUE OCCURRED DURING AN ACL RECONSTRUCTION AND MENISCAL REPAIR PROCEDURE ON (B)(6) 2025. THE ANCHOR REMAINED IN THE PATIENT, AND THE FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-4030C-10 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW FROM LOT NUMBER 15156623. THE CASE PROCEEDED WITHOUT DELAY, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED.

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

  MAUDE report 23322260 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREW BROKE INTO TWO PARTS DURING IMPLANTATION. THE BROKEN PART WAS 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 22663135 ↗
• MalfunctionSep 13, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE DURING INSERTION. ALL FRAGMENTS 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 20214221 ↗
• MalfunctionSep 3, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE SCREW BROKE OFF WHEN SCREWING IN. THE BROKEN PIECES WAS 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 20126742 ↗
• MalfunctionJul 9, 2024Crack; Crack

  ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-4030C-10 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW CRACKED DURING INSERTION. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THERE WAS A MINUTE DELAY IN THE PROCEDURE. THE CASE WAS COMPLETED USING ANOTHER AR-4030C-10 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW WITH NO ISSUES. THIS WAS DISCOVERED DURING A ACL REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702559 ↗
• MalfunctionJun 3, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT SURGERY THE DEVICE COULD NOT BE SCREWED IN. 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 19448372 ↗
• MalfunctionMay 10, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE DURING INSERTION. 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 18-APR-2024 IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19294206 ↗
• MalfunctionMay 7, 2024Failure to Advance; Failure to Advance

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4030C-10 FASTT HREAD SCREW COULD NOT LONGER ADVANCE BECAUSE THE DRIVER HEX THREADS SPUN OUT. THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2021. THE FAILED SCREW WAS REMOVED WITHOUT ANY BROKEN FRAGMENTS AND A NEW ONE WAS IMPLANTED WITH NO FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 19257753 ↗
• MalfunctionMay 2, 2024Break; Break

  ON 03/01/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-4030C-10 SCREW IS CRACKED. THIS WAS DISCOVERED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 03/01/2022: THE SCREW CRACKED IN A BTB ACL RECONSTRUCTION, AND THE SCREW WAS BEING USED IN THE TIBIA FOR BONE BLOCK INTERFERENCE. THE SURGEON PREPPED THE BONE WITH A TAP FIRST. THEN HE TWISTED THE SCREW ABOUT TWO TIMES AND THE SCREW CRACKED HORIZONTALLY LEAVING HALF THE SCREW IN THE PATIENT, AND THE OTHER HALF ON THE DRIVER. THE FRAGMENT WAS RETRIEVED, AND THE CASE WAS COMPLETED USING A NEW SCREW WITH A DIFFERENT LOT NUMBER. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19230172 ↗
• MalfunctionDec 21, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE DURING INSERTION. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18375775 ↗
• InjuryDec 7, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON 11/13/2023, IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL VIA EMAIL THAT A PATIENT IS EXPERIENCING A POSSIBLE ALLERGIC REACTION TO AN AR-4030C-10 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW 10 X 30 MM. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18288786 ↗
• MalfunctionOct 25, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE SURGERY THE ANCHOR BROKE INSIDE THE PATIENT DURING INSERTION. IT WAS POSSIBLE TO RETRIEVE THE BROKEN PIECES FROM 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. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004541 ↗
• MalfunctionAug 17, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-4030C-09 INTERFERENCE SCREW, AND A AR-4030C-10 INTERFERENCE SCREW BROKE. THIS OCCURRED DURING AN ACL PROCEDURE ON (B)(6) 2023 WHILE SCREWING THE AR-4030C-09 IN IT CRACKED AND BROKE INTO 2, THERE WAS A 5-MINUTE DELAY IN RETRIEVING THE FRAGMENTS AND GRABBING THE AR-4030C-10. WHILE SCREWING THE AR-4030C-10 THE SAME ISSUE OCCURRED IT CRACKED AND BROKE INTO 2, THERE WAS ANOTHER 5-MINUTE DELAY IN RETRIEVING THE FRAGMENTS AND GRABBING THE 10X28 SCREW TO COMPLETE THE CASE. THE PATIENT HAD PRETTY GOOD BONE QUALITY, AND A 9MM REAMER WAS USED TO PREPARE THE BONE SOCKET FOR INSERTION.

  Patient problems: Insufficient Information

  MAUDE report 17565325 ↗
• MalfunctionMar 22, 2023Break; Break

  IT WAS REPORTED THAT DURING A PRIMARY ACL RECONSTRUCTION PROCEDURE THE SCREW BROKE INSIDE THE TIBIAL TUNNEL DUE TO NOT ENGAGING THE SCREWDRIVER. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16589693 ↗
• InjuryJan 30, 2023Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE DURING INSERTION. 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: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16263736 ↗
• MalfunctionOct 31, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY DURING TIBIAL FIXATION THE DEVICE BROKE OFF. 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 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 15698353 ↗
• MalfunctionSep 26, 2022Break

  ON 9/7/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-4030C-10 FASTTHREAD¿ BIOCOMPOSITE¿ INTERFERENCE SCREW 10 X 30 MM HAD AN ISSUE. DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2022 DURING A SOFT TISSUE ALLOGRAFT, WHEN THE SURGEON TRIED TO INSERT THE SCREW, HE ALMOST GOT ALL THE WAY THROUGH, BUT THEN HAD TO BACK THE SCREW OUT AND NOTICED THAT PART OF THE THREAD OF THE SCREW HAD BROKEN OFF INSIDE THE PATIENT. HE WAS ABLE TO REMOVE THE FRAGMENT, THE BROKEN THREAD, AND THE SCREW, AND USED ANOTHER AR-4030C-10 FASTTHREAD¿ BIOCOMPOSITE¿ INTERFERENCE SCREW 10 X 30 MM, LOT NUMBER UNKNOWN, TO COMPLETE THE CASE SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. THE COMPLAINT DEVICE HAS BEEN DISCARDED, BUT A PICTURE WAS TAKEN OF THE BROKEN COMPLAINT DEVICE BEFORE IT WAS DISCARDED, AND WAS PROVIDED VIA EMAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15484161 ↗
• MalfunctionJul 5, 2022Break; Entrapment of Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGERY USING STANDARD TECHNIQUE TIGHTROPE IN FEMUR AND SCREW IN THE TIBIA WITH GRAFT DIAMETER WAS 9.5 MM AFTER COMPRESSION, THE SCREW BROKE DURING FIXATION. 50% OF THE SCREW REMAINS INSIDE THE TIBIAL TUNNEL. IT WAS NOT RETRIEVED FROM PATIENT. A SECOND FIXATION OF THE GRAFT DONE WITH SWIVELOCK 5.5 MM. THE TIBIAL TUNNEL WAS DONE 9.5 MM. A 10 MM TAPPING WAS DONE AND GRAFT PASSED SUCCESSFULLY. A FAST THREAD SCREW SIZE 10X30 WAS OPENED AND SCREWDRIVER AR-1996CD WAS USED FOR THE PROCEDURE. THE PURCHASING OF THE SCREW TO THE SCREW DRIVER WAS NOT COMPLETE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 17-JUN-2022 ADDITIONAL INFORMATION RECEIVED: THE SCREWDRIVER GOES THROUGH THE SCREW ONLY HALFWAY. IT SHOULD GO MORE INSIDE THE SCREW TO FIT COMPLETELY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14914720 ↗
• MalfunctionFeb 21, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT GRAFT KNEE ARTHROSCOPY THE DEVICE BROKE DURING PLACEMENT IN THE TIBIA. ALL FRAGMENTS 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: Foreign Body In Patient

  MAUDE report 13569610 ↗
• MalfunctionSep 14, 2021Break; Crack

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY WHILE IMPLANTING THE SCREW IT CRACKED AND BROKE IN TWO WHEN THE SURGEON REMOVED IT. THE SURGEON WAS ABLE TO RETRIEVE THE IMPLANT AND THE DEBRIS 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467121 ↗
• InjuryJun 26, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2019 WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-1588RT-J LOT: 10259067, AR-1897S LOT: 10224925, AR-4030C-10 LOT: 10198681, AR-7209T LOT: 12863, JRF SPEEDGRAFT ID: (B)(4) (NOT AN ARTHREX PRODUCT). THIS CASE WAS COMPLETED WITH NO ISSUE. THE PATIENT WAS SEEN FOR HIS FIRST POST-OP VISIT ON (B)(6) 2019 AND PER THE PA: ¿SKIN INTACT; PORT AND GRAFT INCISIONS CLEAN, DRY AND INTACT WITH SUTURES. NO ERYTHEMA OR SIGNS OF INFECTION. MILD REDNESS SECONDARY TO SUTURE REACTION.¿ THE PATIENT WAS SEEN FOR A 2ND FOLLOW-UP VISIT AND THE SURGEON REPORTED: ¿35ML OF SEROSANGUINOUS FLUID ASPIRATED FROM THE RIGHT KNEE AFTER ALCOHOL PREP, NO HINT OF TURBCLITY.¿ THIS WAS DONE IN RESPONSE TO INCREASED DWELLING AND DISABILITY FOR THREE DAYS. SURGEON REPORTS: ¿NOT CLINICALLY A DVT; INFECTION A CONCERN, BUT ALSO, CLINICALLY, DOES NOT LOOK LIKE IT.¿ PATIENT WAS PLACED ON BACTRIMDS BY MOUTH TWICE DAILY FOR SEVEN DAYS. THE FLUID WAS SENT FOR CELL COUNT. PER THE REPORT, THE FLUID WAS CLOUDY WITH TOTAL NUCLEATED CELL COUNT AT 6800 AND NEUTROPHILS AT 75. THE PATIENT WAS SEEN FOR HIS THIRD POST-OP FOLLOW UP VISIT ON (B)(6) 2019. T

  Patient problems: Fluid Discharge; Loss of Range of Motion; Pain; Skin Inflammation; Unspecified Infection

  MAUDE report 8734907 ↗