Arthrex® AR-2257Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867026391), received between Jul 8, 2016 and Apr 1, 2026 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionApr 1, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE ACROMIOCLAVICULAR JOINT RECONSTRUCTION, THE SUTURE OF THE TIGHTROPE TORE DURING TENSIONING. ALL BROKEN PIECES 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 24752992 ↗
• MalfunctionApr 21, 2025Break; Fitting Problem; Break; Fitting Problem

  ON 7TH APRIL 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2257, AC TIGHTROPE¿ REPAIR KIT, TITANIUM, THE SUTURE BROKE WHEN RETRIEVING. THIS WAS DETECTED DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF LEFT CLAVICLE FRACTURE SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A NEW AR-2257. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875187 ↗
• MalfunctionMar 14, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-2257 AC TIGHTROPE¿ REPAIR KIT IMPLANT SUTURES BROKE. THIS OCCURRED DURING USE WHEN THE DOCTOR PULLED THE SUTURES TO TIGHTEN THE BUTTON. AS A RESULT, THE IMPLANT COULD NOT BE USED.

  Patient problems: Insufficient Information

  MAUDE report 21608013 ↗
• MalfunctionMar 10, 2025Break; Break

  ON 2/14/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT THE SUTURES FROM AN AR-2257 AC TIGHTROPE REPAIR KIT BROKE WHEN PASSING IT THROUGH THE TUNNEL. WHEN THE SURGEON SLIGHTLY TENSIONED THE SUTURES, THEY BROKE. THE CASE WAS COMPLETED USING ANOTHER PRODUCT. THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 2/25/2025: THE CASE WAS COMPLETED USING ANOTHER AR-2257 AC TIGHTROPE REPAIR KIT. THERE WAS NO DELAY IN THE CASE, AND FURTHER ANESTHESIA WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558724 ↗
• MalfunctionJun 6, 2024Break; Break

  ON 11TH MAY 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2257, AC TIGHTROPE¿ REPAIR KIT, TITANIUM, WAS BROKEN WHEN THE SURGEON PULLED THE SUTURE STRAND. THIS WAS DETECTED DURING USE IN A FIXATION OF SHOULDER DISLOCATION SURGERY ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW AR-2257 WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 19478266 ↗
• InjuryJul 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 6/12/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2257 AC TIGHTROPE WAS IMPLANTED DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF THE LEFT CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2023. ONE MONTH LATER, AN X-RAY SCAN SHOWED THE PLATE WAS LOOSENED. A REVISION SURGERY WAS PERFORMED TO REMOVE THE PLATE AND A PRODUCT FROM ANOTHER COMPANY WE USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 6/13/2023: THE PLATE THAT WAS LOOSENED WAS FROM ANOTHER MANUFACTURE. THE AR-2257 AC TIGHTROPE WAS EXPLANTED DURING THE REVISION SURGERY ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 17266534 ↗
• InjuryApr 25, 2023Break; Break

  ON 3/29/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT A PATIENT UNDERWENT A PROCEDURE FOR DISLOCATION OF THE LEFT ACROMIOCLAVICULAR JOINT ON (B)(6) 2022. IT WAS DISCOVERED THROUGH A NUCLEAR MAGNETIC EXAMINATION ON (B)(6) 2023, THAT THERE WAS A DISLOCATION OF THE ACROMIOCLAVICULAR JOINT. ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION SURGERY AND GOT THE IMPLANTS REMOVED. DURING THE PROCEDURE, IT WAS FOUND THAT THE TIGHTROPE WAS BROKEN. THE CASE WAS COMPLETED WITH STEEL PLATE FIXATION. ADDITIONAL INFORMATION RECEIVED ON 4/4/2023. DURING THE REVISION SURGERY, AR-2257 AC TIGHTROPE WAS EXPLANTED. THE STEEL PLATE USED TO COMPLETE THE PROCEDURE IS A PRODUCT FROM ANOTHER MANUFACTURER.

  Patient problems: Joint Dislocation

  MAUDE report 16808910 ↗
• InjuryJun 21, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN AC REPAIR WITH AC TIGHT ROPE THE BLUE SUTURES FAILED TO TENSION. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2018.

  Patient problems: No Information

  MAUDE report 7624595 ↗
• InjuryFeb 15, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD THE FIRST SURGERY IN (B)(6). ON THE FIRST SURGERY AN AR-2257 WAS IMPLANTED. POST-OP, THE PATIENT COMPLAINED ABOUT PAIN IN THE SHOULDER AND WENT TO A DIFFERENT HOSPITAL IN (B)(6). THE SURGEON DECIDED ON A 2ND SURGERY AND REMOVED THE IMPLANTED BUTTON. THE SURGEON DID NOT IMPLANT A NEW DEVICE. AFTER THE 2ND SURGERY THE PATIENT FIRST FELT BETTER BUT NOW COMPLAINS AGAIN ABOUT SHOULDER PAINS.

  Patient problems: Pain

  MAUDE report 7273910 ↗
• InjuryJul 8, 2016Device Operates Differently Than Expected

  IT WAS REPORTED THAT PATIENT HAD SUSTAINED A RIGHT SHOULDER GRADE 2-3 ACROMIOCLAVICULAR (AC) SEPARATION ON (B)(6) 2014 DURING A MOTORCYCLE ACCIDENT. PATIENT UNDERWENT AN OPEN REDUCTION, TIGHTROPE FIXATION RIGHT ACROMIOCLAVICULAR (AC) JOINT PROCEDURE ON (B)(6) 2014. AT PATIENT'S FIRST POST-OPERATIVE VISIT ON (B)(6) 2014, DISPLACEMENT OF HIS PREVIOUSLY REDUCED AC JOINT WAS NOTED. PATIENT UNDERWENT A RIGHT SHOULDER AC JOINT OPEN REDUCTION AND HARDWARE REVISION WITH CONOID LIGAMENT REPAIR ON (B)(6) 2014. THE OP REPORT NOTES THAT INTRAOPERATIVE FINDINGS FOUND THE TIGHTROPE WAS STILL WELL POSITIONED BUT THAT THERE WAS EVIDENCE OF SUTURE FAILURE AT THE DORSAL BUTTON. REVISION OP REPORT NOTES THE DORSAL BUTTON WAS REMOVED. THE CORACOID BUTTON WAS NOTED TO BE WELL SCARRED IN AND NOT PALPABLE. VISUALIZATION UNDER FLUOROSCOPY FOUND THE BUTTON POSITION TO BE UNCHANGED. OP REPORT DOES NOT INDICATE THAT THIS BUTTON WAS REMOVED. THE REVISION PROCEDURE WAS COMPLETED USING A TIGHTROPE DEVICE.

  Patient problems: No Code Available

  MAUDE report 5778275 ↗