Arthrex® AR-5035TC-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867035508), received between Aug 23, 2016 and Jun 19, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW THREAD PEELED OFF DURING THE FIRST FEW TURNS AND IT WAS THEREFORE NO LONGER POSSIBLE TO IMPLANT THE SCREW. NO PART OF THE DEVICE BROKE OFF. THE DIAMETER OF THE BONE TUNNEL WAS 8 MM AND THE DIMENSIONS OF THE DEVICE ARE 9 MM X 35 MM. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (8X28 MM; AR-5028C-08). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566915 ↗
• MalfunctionApr 9, 2024Defective Device; Defective Device

  ON 4/19/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-5035TC-09 BIOCOMPOSITE INTERFERENCE SCREW HAD AN ISSUE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION REQUESTED

  Patient problems: Insufficient Information

  MAUDE report 19071948 ↗
• MalfunctionApr 8, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY DURING INSERTION OF THE SCREW THE FIRST THREADS WERE TURNED OFF AND THE INSERTION WAS NO LONGER POSSIBLE. 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 20-MAR-2024: IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067308 ↗
• MalfunctionMar 13, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 2/23/2023: THIS WAS DISCOVERED DURING AN ACL PROCEDURE AND COMPLETED USING ANOTHER AR-5035TC-09 CANNULATED DELTA TAPERED BIOCOMPOSITE INTERFERENCE SCREW. ALL THE BROKEN FRAGMENTS WERE RETRIEVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16528578 ↗
• MalfunctionJul 11, 2022Break; Difficult to Insert

  IT WAS REPORTED THAT DURING A SURGERY DURING THE FIRST TWO TURNS, THE SCREW THREAD CAME LOOSE AND A CORRECT INSERTION OF THE SCREW WAS NO LONGER POSSIBLE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH DIFFERENT 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 14976841 ↗
• InjuryAug 23, 2016Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT ON DAY OF THE REVISION PROCEDURE, (B)(6) 2016, THAT SHE HAD UNDERGONE AN ACL RECONSTRUCTION ON (B)(6) 2016 ON HER RIGHT LEG. ON (B)(6) 2016, THE PATIENT BEGAN TO NOTICE EXTREME SWELLING, KNEE WAS HOT TO THE TOUCH, SHE HAD A SKIN RASH WITH WELTS AND BURNING IN AND AROUND THE INCISION. THE REACTION ALSO SPREAD TO THE LATERAL SIDE OF THE FEMUR AND TIBIA. THE PATIENT HAD AN ER VISIT ON (B)(6) 2016 WHERE BLOODWORK WAS TAKEN. RESULTS WERE NEGATIVE FOR INFECTION. SURGEON DECIDED TO BRING PATIENT IN FOR SECOND SURGERY AND POSSIBLE REMOVAL OF THE IMPLANTS. PATIENT STATES THAT PRIOR TO THE (B)(6) 2016 PROCEDURE, SHE HAD ALLERGY TESTING WHICH SHOWED THAT SHE WAS ALLERGIC TO NICKEL. THE FOLLOWING PARTS WERE IMPLANTED DURING THE ORIGINAL (B)(6) 2016 PROCEDURE: AR-1934BCF LOT 1240957 ((B)(6)), AR-1934BCF LOT 1240946 ((B)(6)), AR-2324BCC LOT 10025466 ((B)(6)) AND AR-5035TC-09 LOT 1314851 ((B)(6)). ON (B)(4) 2016, THE SURGEON REPORTED THAT DURING THE (B)(6) 2016 SECOND SURGERY, NO ARTHREX PRODUCTS WERE EXPLANTED. THE SURGEON PERFORMED A SYNOVECTOMY WITH IRRIGATION & DEBRIDEMENT. SURGEON STATED THAT THE REPAIR LOOKED GOOD. SURGEON STATES THAT THE PATIENT SYMPTOMS APPE

  Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Rash; Swelling; Unspecified Infection

  MAUDE report 5897903 ↗