Arthrex® AR-4020C-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867276987), received between Mar 31, 2021 and Feb 11, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Material Deformation; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 15-JUN-2026:THE PATIENT UNDERWENT ACL RECONSTRUCTION OF THE LEFT KNEE ON (b)(6) 2025. ON (b)(6) 2025 (7 MONTHS POST-OPERATIVELY), THE PATIENT NOTED INCREASED SWELLING AND A NODULE BENEATH THE TIBIAL INCISION. DUE TO PERSISTENT SYMPTOMS, FURTHER EVALUATION WAS PERFORMED ON (b)(6) 2025. MRI OBTAINED ON (b)(6) 2025 DEMONSTRATED TIBIAL TUNNEL CYSTS WITH A 2.3 CM MULTILOCULAR PRETIBIAL CYSTIC LESION.DURING THE REVISION PROCEDURE ON (b)(6) 2026, EXCISION OF THE PREVIOUSLY IMPLANTED AR-4020C-10 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW (10 X 20 MM) AND CYSTIC CHANNELS WAS PERFORMED WITH SUBSEQUENT BONE GRAFTING. INTRAOPERATIVELY, CATABOLIC TISSUE WAS NOTED WITHIN THE TIBIAL TUNNEL.

  Patient problems: Cyst(s); Failure of Implant

  MAUDE report 24315953 ↗
• 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 24130584 ↗
• MalfunctionJul 9, 2025Positioning Failure; Failure to Advance; Positioning Failure; Failure to Advance

  ON 06/12/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT (QTY. 2) OF AN AR-4570-24 FIBERSTITCH IMPLANT FAILED FIXATION IN THE MENISCUS. WHILE THE FAILURE WAS ATTRIBUTED TO THE QUALITY OF THE MENISCUS, THE SURGEON WAS UNABLE TO COMPLETE THE INTENDED REPAIR USING EITHER DEVICE. FOLLOWING THIS, AN AR-4020C-10 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW WAS INSERTED BUT DID NOT SEAT PROPERLY. A LARGER SCREW WAS THEN REQUESTED, WHICH ACHIEVED FIXATION AND WAS FURTHER REINFORCED WITH A SWIVELOCK. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 06/24/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455797 ↗
• MalfunctionJan 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  UPDATE NROE 25-JAN-2024: FURTHER INFORMATION WAS PROVIDED AND REVEALED THAT THE INCIDENT OCCURRED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18582087 ↗
• MalfunctionJan 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  UPDATE NROE 25-JAN-2024: FURTHER INFORMATION WAS PROVIDED AND REVEALED THAT THE INCIDENT OCCURRED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18582081 ↗
• InjuryOct 6, 2023Break; Break

  ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT ACL REVISION RECONSTRUCTION WITH AUTOGRAFT, MEDIAL MENISCUS REPAIR, AND PARTIAL LATERAL MENISCECTOMY. IT WAS REPORTED THAT DURING THE COURSE OF THE OPERATION, IN PERFORMING A REPAIR OF THE MEDIAL MENISCUS, AN INTRA-MENISCAL REPAIR DEVICE CALLED A FIBERSTITCH MADE BY ARTHREX WAS USED TO REPAIR THE MEDIAL MENISCUS. DURING THE MENISCUS REPAIR, A PORTION OF THE DEVICE BROKE AND WAS LEFT BEHIND IN THE PATIENT¿S KNEE. ALSO, DURING THIS PROCEDURE, THE SURGEON CLEARED THE KNEE OF A PREVIOUSLY IMPLANTED GRAFT AND FIBERWIRE SUTURES. BETWEEN (B)(6) 2021, AND (B)(6) 2021, THE PATIENT HAD CONTINUOUS CALLS AND FOLLOW-UPS WITH HIS PHYSICIAN REPORTING SIGNIFICANT PAIN. ON (B)(6) 2021, AN X-RAY WAS TAKEN, WHICH REVEALED A FOREIGN BODY INSIDE THE RIGHT KNEE. ON (B)(6) 2021, A SECOND SURGERY WAS PERFORMED TO REMOVE THE FOREIGN BODY. DURING THE REMOVAL PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD SIGNIFICANT SYNOVITIS THROUGHOUT THE KNEE JOINT WITH FAILED MEDIAL MENISCUS REPAIR AND A RETAINED DEVICE FRAGMENT. IT WAS NOTED THAT THE FRAGMENT WAS 2 CM IN LENGTH. THE MEDIAL MENISCUS WAS NOT REPAIRED AT THIS TIME. THE PATIENT HAS HAD CONTINUED PAIN, INFECTIONS,

  Patient problems: Synovitis

  MAUDE report 17890061 ↗
• MalfunctionApr 18, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-4020C-10 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW BROKE IN HALF AS IT WAS GETTING INSERTED. INITIALLY THE SURGEON WAS HAVING TROUBLE LOADING THE DRIVER ON THE SCREW, AS IT WAS NOT SEATING PROPERLY, EVENTUALLY SURGEON WAS ABLE TO SCREW IN IT WHEN IT BROKE. EVERYTHING WAS RETRIEVED FROM THE PATIENT AND CASE WAS COMPLETED WITH ANOTHER AR-4020C-10 SCREW WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION WITH PATELLA ALLOGRAFT PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14136560 ↗
• MalfunctionMar 31, 2021Break; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING AN ACL MENISCUS REPAIR THE FIRST IMPLANT DEPLOYED BUT DID NOT STAY IMPLANTED AND CAME BACK OUT. IT WAS REPLACED AND THE CASE WAS CONTINUED. THEN WHEN THE AR-4020C-10 SCREW WAS IMPLANTED IT BROKE ON INSERTION. ALL WAS RETRIEVED AND IT WAS REPLACED WITH AN AR-4030C-10 AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

  Patient problems: Failure of Implant

  MAUDE report 11599061 ↗