Arthrex® AR-2370BLRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867340138), received between Jul 6, 2023 and Sep 19, 2025 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ACROMIOCLAVICULAR JOINT SURGERY A TIGHTROPE WAS USED. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2025. AFTER THE SURGERY THE DEVICE TORE INSIDE THE PATIENT. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. THE REVISION SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER.

  Patient problems: Failure of Implant

  MAUDE report 23095042 ↗
• MalfunctionMay 13, 2025Break; Break

  ON 4/17/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2370BL KNOTLESS AC TIGHTROPE WITH DOG BONE BUTTON REPAIR SYSTEM WAS INVOLVED IN AN INTRAOPERATIVE ISSUE DURING AN AC RECONSTRUCTION PROCEDURE ON (B)(6) 2025. DURING THE SURGERY, THE SURGEON DRILLED THROUGH THE CLAVICLE AND CORACOID USING AN AR-2257D-30 DRILL AND PASSED A PASSING WIRE. THE TIGHTROPE WAS PLACED, AND THE DOG BONE BUTTON WAS SECURED ONTO THE CORACOID. HOWEVER, WHILE ATTEMPTING TO TIGHTEN THE TIGHTROPE, THE SURGEON ENCOUNTERED DIFFICULTY GETTING IT TO SLIDE PROPERLY. UPON APPLYING ADDITIONAL FORCE, THE PULL SUTURE SNAPPED AT THE TIGHTROPE MECHANISM. AS A RESULT, THE SURGEON HAD TO CUT THE TIGHTROPE OFF THE CLAVICLE SIDE AND REMOVE THE DOG BONE BUTTON FROM BENEATH THE CORACOID. THE COMPONENTS WERE FULLY REMOVED, AND THE AC RECONSTRUCTION WAS COMPLETED USING AN AR-2370BL KNOTLESS AC TIGHTROPE WITH DOG BONE BUTTON REPAIR SYSTEM. THE ISSUE CAUSED APPROXIMATELY A TWO-MINUTE DELAY, BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AS CONFIRMED BY THE CRNA IN THE OPERATING ROOM.

  Patient problems: Insufficient Information

  MAUDE report 22008492 ↗
• InjuryFeb 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE IMPLANT HAS TORN WITHIN THE FIRST SIX WEEKS. NO FURTHER INFORMATION RECEIVED. UPDATE DW 14-JAN-2025: FURTHER INFORMATION WAS PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2024 AND THE REVISION TOOK PLACE ON (B)(6) 2024. THE TORN IMPLANT WAS REMOVED AND REPLACED WITH AN NEW ONE IMPLANT AND THE GRACILIS.

  Patient problems: Failure of Implant

  MAUDE report 21321355 ↗
• InjuryFeb 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE IMPLANT HAS TORN WITHIN THE FIRST SIX WEEKS. NO FURTHER INFORMATION RECEIVED. UPDATE DW 14-JAN-2025: FURTHER INFORMATION WAS PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2024 AND THE REVISION TOOK PLACE ON (B)(6) 2024. THE TORN IMPLANT WAS REMOVED AND REPLACED WITH AN NEW ONE IMPLANT AND THE GRACILIS.

  Patient problems: Failure of Implant

  MAUDE report 21321254 ↗
• InjuryFeb 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE IMPLANT HAS TORN OUT VENTRALLY WITHIN THE FIRST SIX WEEKS. NO FURTHER INFORMATION RECEIVED. UPDATE DW 14-JAN-2025: FURTHER INFORMATION WAS PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2024 AND THE REVISION TOOK PLACE ON (B)(6) 2024. THE TORN IMPLANT WAS REMOVED AND REPLACED WITH AN NEW ONE IMPLANT AND THE GRACILIS.

  Patient problems: Failure of Implant

  MAUDE report 21321217 ↗
• MalfunctionFeb 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE IMPLANT HAS TORN WITHIN THE FIRST SIX WEEKS. NO FURTHER INFORMATION RECEIVED. UPDATE DW 14-JAN-2025: FURTHER INFORMATION WAS PROVIDED THAT THE PATIENT DID NOT WANT AN ADDITIONAL SURGERY AND THEREFORE NO ADDITIONAL TREATMENT WAS PERFORMED. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 21314355 ↗
• MalfunctionJun 28, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT HAD TO BE REVISED TODAY DUE TO A NEW CLAVICLE ELEVATION. THE SUTURE LOOP WAS FIRM AND INTACT ABOVE THE BUTTON BUT THE TENSION HAD GIVEN WAY. THE PROBLEM WAS NOTICED AFTER THE SURGERY. THE ITEM WAS COMPLETELY RECOVERED AND A NEW ITEM WAS IMPLANTED. THE OLD IMPLANTED DEVICE WAS DISPOSED. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

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

  MAUDE report 19638407 ↗
• MalfunctionApr 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH AN AC TIGHTROPE SYSTEM ON THE (B)(6) 2023. THE SYSTEM BECAME LOOSE. THE PATIENT CHECKED IN POST-OP AND AN X-RAY WAS PERFORMED. THE PATIENT HAD A GRADE 5 INJURY. THE SURGERY WAS DONE IN THE FIRST TWO WEEKS. THE SURGEON DID NOT PERFORM ANY VERTICAL STABILISATION. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 28-MAR-2024. IT WAS CONFIRMED THAT THE PATIENT HAD A GRADE 5 INJURY PRIOR TO THE INITIAL SURGERY. THE FAILURE WAS DETECTED IN THE XRAY IN THE FIRST APPOINTMENT AFTER SURGERY. NO ACTIONS WERE TAKEN SO FAR TO TREAT THE PATIENT AFTER THE LOOSENING OF THE DEVICE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19153380 ↗
• MalfunctionNov 21, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 10/25/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE TIGHTROPE FROM AN AR-2370BL KNOTLESS AC TIGHTROPE REPAIR IMPLANT WITH DOG BONE BUTTON GOT JAMMED. THE SURGEON DRILLED THE TUNNELS THROUGH THE CLAVICLE AND CORACOID, AND AN SD WIRE LOOP WAS PASSED. THE KNOTLESS AC TIGHTROPE WAS PASSED, AND A DOG BONE BUTTON WAS ATTACHED. THE DOG BONE BUTTON WAS PLACED ON THE CORACOID, AND THE CLAVICLE BUTTON WAS WALKED DOWN TO THE CLAVICLE, BUT BEFORE THE CLAVICLE BUTTON WAS TIGHT TO THE CLAVICLE, THE TIGHTROPE GOT JAMMED. THE SURGEON USED KITE HANDLES TO PULL ON THE TIGHTROPE TAILS WITH FORCE WHILE THE PHYSICIAN ASSISTANT HELD THE REDUCTION ON THE CLAVICLE. AFTER PULLING ON IT HARD, THE BUTTON DID NOT GET TIGHT TO THE CLAVICLE AND THE WHITE PULL SUTURE ON ONE OF THE KITE HANDLES SNAPPED RIGHT AT THE TIGHTROPE MECHANISM. THE SURGEON CUT THE CLAVICLE BUTTON OFF AND USED THE SUTURES TO PASS ANOTHER TIGHTROPE TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN AC JOINT RECONSTRUCTION PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18184400 ↗
• InjuryJul 6, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN ACROMIOCLAVICULAR (AC) JOINT REPAIR SURGERY WHEN THE IMPLANT WAS TIGHTENED, THE SUTURE MIGRATED THROUGH THE CORACOID BONE AND LEFT A FISSURE. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE BY CHANGING TO A CLASSICAL DOG BONE TECHNIQUE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 17269236 ↗