Arthrex® AR-2371Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867256637), received between Dec 28, 2020 and Mar 6, 2026 — classified as 4 injuries, 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Break

  ON 13-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-2371 LOW PROFILE AC TIGHTROPE IMPLANT SYSTEM BROKE DURING PLACEMENT INSIDE THE PATIENT. ALL BROKEN COMPONENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT USING AN ADDITIONAL AR-2370 IMPLANT (LOT 15172469). THERE WAS NO SIGNIFICANT SURGICAL DELAY, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. THE ISSUE OCCURRED DURING AN AC LIGAMENT RECONSTRUCTION PROCEDURE PERFORMED ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 19-FEB-2026: AT THIS TIME, IT IS UNKNOWN WHICH PORTION OR COMPONENT OF THE AR-2371 LOW-PROFILE AC REPAIR SYSTEM BROKE IN THE PATIENT. HOWEVER, IT WAS CONFIRMED THAT ALL MATERIAL, INCLUDING ANY BROKEN FRAGMENTS, WAS COMPLETELY REMOVED FROM THE PATIENT BEFORE A NEW DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531361 ↗
• InjuryMar 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 22ND FEBRUARY 2023, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-2371, HAD LOOSENED, POST-OPERATION. THIS WAS DETECTED DURING 2-MONTH POST-OPERATIVE X-RAY, ON (B)(6)2023. A SURGEON HAD IMPLANTED THE TIGHTROPE FOR A CLAVICLE FRACTURE CASE ON (B)(6) 2023. THE AC JOINT WAS SUCCESSFULLY REDUCED INITIALLY. HOWEVER, FROM THE 2-MONTH POST-OPERATIVE X-RAY, THE SURGEON DISCOVERED THAT THE IMPLANT WAS LOOSENED AND HENCE THE AC JOINT IS ONCE AGAIN DISLOCATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18850308 ↗
• MalfunctionDec 10, 2023Failure to Advance; Failure to Advance

  ON 11/14/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARITY EMPLOYEE VIA EMAIL THAT THE SUTURES FROM AN AR-2371 LOW PROFILE AC TIGHTROPE IMPLANT SYSTEM DID NOT GO THROUGH THE BUTTONHOLE. ALSO, THE CHINESE FINGER TRAPPED WAS PLACED IN AN UNUSUAL POSITION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 11/17/2023: THE CHINESE FINGER TRAP, WHICH IS THE BLACK AND WHITE SUTURES, WERE LOCATED DISTAL TO THE TOP HAT BUTTON. THIS WAS DISCOVERED UPON OPENING THE PACKAGE. THE CASE WAS COMPLETED USING ANOTHER AR-2371 LOW PROFILE AC TIGHTROPE IMPLANT SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 18298475 ↗
• InjuryOct 27, 2023Expiration Date Error; Expiration Date Error

  PER SALES REPRESENTATIVE, THE SURGEON REPORTED THAT HE IMPLANTED AN EXPIRED IMPLANT INTO THE PATIENT IN JULY. THE PATIENT GOT AN INFECTION BUT IT IS UNCLEAR IF THE INFECTION WAS CAUSED BY THE EXPIRED IMPLANT. PER SYSTEM, THE DEVICE EXPIRATION DATE IS 31-DEC-2023 AND WAS NOT EXPIRED DURING IMPLANTATION. ***UPDATE (B)(6) 2023 NROE: FURTHER INFORMATION REVEALED THAT THE PART ID WAS ENTERED INCORRECTLY. THE EXPIRATION DATE OF THE CORRECT PART ID IS 31-MAY-2023, SO THE IMPLANT WAS, IN FACT, EXPIRED DURING IMPLANTATION. THE CUSTOMER WAS REPEATEDLY INFORMED THAT THE IMPLANT HAD EXPIRED. THE PROCEDURE PERFORMED WAS AN AC JOINT REPAIR SURGERY. AN ADDITIONAL SURGERY WAS PERFORMED AT THE END OF AUGUST DUE TO THE INFECTION. ***UPDATE (B)(6) 2023 NROE: ADDITIONAL INFORMATION WAS PROVIDED AND REVEALED THAT IN THE ADDITIONAL SURGERY IN AUGUST THE INFECTION WAS TREATED. ALSO IT WAS REPORTED THAT THREE OTHER ARTHREX IMPLANTS WERE IMPLANTED IN THE INITIAL SURGERY IN JULY. THE IMPLANTS WERE NOT REMOVED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 18023521 ↗
• MalfunctionJul 6, 2023Break; Break

  ON 06/15/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT THE 3MM HOLLOW DRILL INCLUDED IN THE AR-2371 LOW PROFILE AC TIGHTROPE® IMPLANT SYSTEM, DID NOT PASS SMOOTHLY THROUGH THE AR-2255CG-05 AND BROKE OFF. A NEW DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED 6/21/2023: THE EVENT OCCURRED DURING AN ACROMIOCLAVICULAR JOINT DISLOCATION REPAIR PROCEDURE. THE BROKEN PIECES WERE ON THE EXTRACORPOREAL SIDE AND RETRIEVED WITHOUT INCIDENT AND THE ONE STUCK IN THE DRILL WAS EXTRACTED PER GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17270252 ↗
• InjuryApr 4, 2022Break; Output Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2371 LOW-PROFILE AC REPAIR SYSTEM HAD AN ISSUE. THE DEVICE WAS INITIALLY USED ON (B)(6) 2021 DURING AN AC SHOULDER JOINT RECONSTRUCTION, NO ISSUES WERE REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. THE PATIENT HAD A FEW MONTH OF PHYSICAL THERAPY, AND 2-3 MONTHS POST OPERATIVELY HE NOTICED THE CLAVICLE STARTED TO RISE AGAIN. THE DOCTOR SCHEDULED X-RAYS, THE CLAVICLE WAS RAISED AGAIN, THE 2 BUTTONS HAD COME UNDONE, AND THE DEVICE HAD LOST ALL TENSION. A REVISION SURGERY WAS PERFORMED BY THE SAME SURGEON (WHO PERFORMED THE FIRST SURGERY) ON (B)(6) 2022, AND IT WAS FOUND THAT THE SUTURE BETWEEN THE TWO BUTTONS HAD BROKEN. THEY PULLED OUT THE CLAVICLE BUTTON AND THEY LEFT THE SECOND BUTTON WHICH WAS SEATED UNDERNEATH THE CORACOID IN THE PATIENT. THE DOCTOR DID NOT WANT TO USE THE SAME SYSTEM, SO HE USED NEW SUTURES ( AR-7237, LOT NUMBER UNKNOWN, AND ANOTHER PRODUCT FROM A COMPETITOR) AND A GRAFT, AND TIED THE GRAFT TO THE CLAVICLE WITH THE NEW SUTURES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER IMPACT TO THE PATIENT.

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

  MAUDE report 13994802 ↗
• InjuryDec 28, 2020Break

  IT WAS REPORTED THAT THE SURGEON HAS IDENTIFIED THAT 4 TO 5 WEEKS AFTER THE INITIAL SURGERY THE LOW PROFILE SCREW GOT BROKEN. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED AFTER THE SURGERY. NO FURTHER INFORMATION RECEIVED. UPDATE 8-DEC-2020 DW. FURTHER INFORMATION WERE PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2020 AND A REVISION WAS PERFORMED ON (B)(6) 2020.

  Patient problems: Insufficient Information

  MAUDE report 11075962 ↗