Arthrex® AR-4020C-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00888867276970), received between Mar 29, 2021 and Aug 28, 2026 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Patient Device Interaction Problem

  On 14-Aug-2026, a sales representative reported via email that a patient who underwent an ACL reconstruction on (b)(6) 2025 developed a caseating granuloma at the tibial screw site. The procedure involved a BTB ACL reconstruction utilizing an AR-4020C-07 FastThread BioComposite Interference Screw (7 x 20 mm) in the femur and an AR-4020C-09 FastThread BioComposite Interference Screw (9 x 20 mm) in the tibia. The reported reaction was localized to the tibial site associated with the AR-4020C-09 screw. No issues were reported with the AR-4020C-07 screw implanted in the femur.Additional information was received on 19-Aug-2026:Follow-up information was received from the surgeon. The surgeon reported that the first signs and symptoms were observed in (b)(6) 2026 and consisted of painful swelling. The surgeon further reported that the diagnosis of a caseating granuloma was based on MRI findings and operative findings. Cyst formation was reportedly identified, and the surgeon suspected the screw contributed to the granuloma because the reaction was localized to the screw location. The surgeon reported that pathology and culture results showed no evidence of infection. Infection was reporte

  Patient problems: Granuloma; Swelling/ Edema

  MAUDE report 50497111 ↗
• MalfunctionMay 20, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY THE SCREW BROKE. 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 25232236 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE OFF AT THE TIP. 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 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 23478900 ↗
• 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 22210399 ↗
• MalfunctionFeb 24, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-4020C-09 FASTTHREAD¿ BIOCOMPOSITE¿ INTERFERENCE SCREW BROKE. THIS OCCURRED DURING AN ACL RECONSTRUCTION ON (B)(6) 2025, WHEN THEY TAPPED TWICE AND IT BROKE. ALL FRAGMENTS WERE ABLE TO BE RETRIEVED FROM THE PATIENT. THE PATIENT HAD DECENT BONE QUALITY, THAT WAS PREPARED USING THE TAP. THE CASE WAS COMPLETED USING ANOTHER AR-4020C-09 FASTTHREAD¿ BIOCOMPOSITE¿ INTERFERENCE SCREW BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446262 ↗
• MalfunctionFeb 4, 2025Break; Break

  ON 01/13/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4020C-09 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW BROKE INTO THREE PIECES DURING USE. THE CASE WAS COMPLETED USING ANOTHER ONE WITH THE SAME LOT NUMBER WITHOUT ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 01/20/2025: AR-4020C-09 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW BROKE INTO THREE PIECES WHILE INSERTING THE SCREW. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THEY USED ANOTHER 9X20 INTERFERENCE SCREW TO COMPLETE THE CASE. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED TO THE PATIENT. THE GRAFT USED IN THE PROCEDURE WAS A QUAD TENDON. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6)2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304205 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE DEVICE BROKE WHILE SCREWING IN. ALL PARTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH ANOTHER DEVICE. A FAST THREAD SCREW WITH 8X23MM WAS USED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19647014 ↗
• MalfunctionJun 27, 2024Break; Break

  IT WAS REPORTED THAT THE SCREW BROKE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE DW 17-JUN-2024: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED EVENT OCCURRED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WHILE THE SCREW WAS BEING INSERTED INTO THE DRILL CHANNEL. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PARTS AND FINISHED THE SURGERY SUCCESSFULLY WITH A DIFFERENT SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624444 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THERE WAS A BREAKAGE OF THE FAST THREAD INTERFERENCE SCREW DURING INSERTION OF THE DEVICE INTO THE FEMORAL BONE TUNNEL. ALL FRAGMENTS 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 19497352 ↗
• MalfunctionMay 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE IMPLANT SPLIT AT THE END. NOTHING BROKE OFF INSIDE THE PATIENT. 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 19257691 ↗
• MalfunctionMay 1, 2024Defective Device; Defective Device

  ON 12/27/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4020C-09 FASTTHREAD SCREW HAD STRUCTURAL DAMAGE AND LOST SHAPE AFTER IT WAS INSERTER. THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2021. SURGEON USED THE PROPER TAP PRIOR OF SCREW INSERTION AND THEN WHEN SCREW WAS PUTTING IT DID NOT WORK AND SURGEON REMOVED IT. IT WAS NOTICED THAT THE LOWER THREADS HAD LOST ITS SHAPE AND SURGEON WAS UNABLE TO USE IT AGAIN. ADDITIONAL INFORMATION RECEIVED ON 12/27/2021: NOTHING BROKE INSIDE THE PATIENT AND CASE WAS COMPLETED USING AN AR-1390E FROM LOT 13435877 WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220681 ↗
• MalfunctionJan 29, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREW BROKE IN THE FEMUR BONE DURING INSTALLATION. 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 18597607 ↗
• InjuryNov 21, 2023Biocompatibility; Biocompatibility

  ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT A RIGHT KNEE ARTHROSCOPY AND ACLR WITH ALLOGRAFT PROCEDURE ON 12/16/2022. ON (B)(6) 2022, THE PATIENT STARTED TO EXPERIENCE ITCHINESS AND SMALL HIVES FORMING ON THE RIGHT LEG NEAR THE SCAR. BY (B)(6) 2022, THE PATIENT NOTICED REDNESS AROUND THE INCISION SITE. THE PATIENT INFORMED THE SURGEON AND WAS GIVEN ANTIBIOTICS AND BENADRYL. BY (B)(6) 2023, THE ISSUE WAS RESOLVED AND THE SKIN LOOKED NORMAL. ON (B)(6) 2023, THE PATIENT NOTICED SWELLING AND REDNESS AT THE INCISION SITE. THE SURGEON PRESCRIBED ANTIBIOTICS BUT, EVENTUALLY, AN ABSCESS-LIKE BUMP FORMED IN THE LEG, WHICH WAS DRAINED IN AN IN-OFFICE PROCEDURE. LATER, THE ABSCESS RE-FORMED AND BURST ON ITS OWN, AND ANOTHER ROUND OF ANTIBIOTICS WAS PRESCRIBED. THE PATIENT UNDERWENT I &D. AS OF (B)(6) 2023, THE PATIENT IS STILL EXPERIENCING REDNESS, SWELLING, PITTING EDEMA IN THE RIGHT LEG, ABSCESS, DRAINAGE, AND WOUND DEHISCENCE. THE PATIENT HAS HAD BLOODWORK AND CULTURES TO FIND THE REACTION CAUSE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18181851 ↗
• MalfunctionJun 7, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY DURING THE INSTALLATION OF THE SCREW, IT BROKE IN TWO PIECES. 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: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17081179 ↗
• MalfunctionMay 2, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREWS BROKE INSIDE THE PATIENT WHEN SCREWING IN WITH THE SCREWDRIVER. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 16857696 ↗
• MalfunctionJan 30, 2023Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY DURING INSERTING THE SCREW THE DISTAL TIP BROKE OFF AND PREVENTED THE IMPLANTATION. THIS INCIDENT OCCURRED WITH A 9X20MM SCREW AND THEN WITH A 9X30MM SCREW. THE BROKEN PIECES WERE RETRIEVED FROM THE 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 16263368 ↗
• MalfunctionNov 7, 2022Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREW BROKE AT THE BEGINNING OF THE INSERTION. THE BROKEN OFF PART WAS RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON, NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743096 ↗
• 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 15698339 ↗
• MalfunctionSep 26, 2022Break; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PATELLAR TENDON SURGERY THE INTERFERENCE SCREW BROKE DURING INSTALLATION. THE SCREW WAS PARTIALLY REMOVED AND FRAGMENTS REMAINED IN THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-4020C-08). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15484126 ↗
• MalfunctionJul 25, 2022Break; Installation-Related Problem

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THERE WAS A FAILURE OF INSTALLATION AT HPJM. THE SCREW BROKE OFF INSIDE THE PATIENT IN THE BONE TUNNEL AT THE BEGINNING OF SCREWING. THE BROKEN PIECE WAS REMOVED FROM PATIENT AND A NEW ONE HAD TO BE USED TO FINISH THE SURGERY SUCCESSFULLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093640 ↗
• MalfunctionJul 5, 2022Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY (ANTERIOR CRUCIATE LIGAMENT) THE SCREW BROKE WHEN IT WAS INSERTED IN THE FEMUR. IT WAS REMOVED FROM PATIENT AND A NEW SCREW HAD TO BE USED TO FINISH THE SURGERY SUCCESSFULLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914611 ↗
• MalfunctionApr 4, 2022Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT LIGAMENTOPLASTY SURGERY THE HEAD OF THE DEVICE BECAME DETACHED FROM THE BODY AT THE TIME OF SCREWING. 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 (AR-4020C-06). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13995364 ↗
• MalfunctionOct 12, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-4020C-09 BIO COMPOSITE 9 X 20 INTERFERENCE SCREW BROKE DURING INSERTION. ALL BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT. THIS WAS DISCOVERED DURING USE IN A ACL REPAIR ON (B)(6) 2021. THE CASE WAS COMPLETED BY A 9 X 23 INTERFERENCE SCREW.

  Patient problems: Insufficient Information

  MAUDE report 12615560 ↗
• MalfunctionSep 28, 2021Break; Difficult to Remove

  IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY SURGERY THE SCREW BROKE OFF WHILE INSERTING. THE BROKEN OFF PIECE HAS NOT BEEN RETRIEVED FROM THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT 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. UPDATE, (B)(6) 2021 RECEIVED FURTHER INFORMATION THAT THE SCREW IS SECURE INSIDE THE FEMUR BONE AND CANNOT BE MOVED/ IS NOT LOOSENING.

  Patient problems: Foreign Body In Patient

  MAUDE report 12540056 ↗
• MalfunctionMar 31, 2021Break

  IT WAS REPORTED THAT DURING A PATELLAR TENDON ALLOGRAFT ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE DEVICE (AR-4020C-09, LOT 11764659) BROKE INSIDE THE PATIENT IN THE MIDDLE OF IMPLANTING IN A 9 MM DIAMETER TIBIAL TUNNEL. THE SURGEON USED A TAP BEFORE INSERTING THE DEVICE AS A BONE TENDON BONE GRAFT. 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 11599597 ↗