Arthrex® AR-2371BLRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867340145), received between Oct 13, 2023 and Mar 6, 2026 — classified as 4 injuries, 7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER A SURGERY THE KNOTLESS AC TIGHTROPE AR-2371BL TORE AND THE CLAVICLE RE-ASCENDED. NO FURTHER INFORMATION WAS PROVIDED. UPDATE 19-FEB-2026. IT WAS CONFIRMED THAT THE INITIAL SURGERY WAS PERFORMED IN (B)(6) 2025 AND THE INCIDENT OCCURRED WHEN THE PATIENT ALLEGEDLY "CAUGHT A TELEVISION". THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2026. THE PATIENT WAS TREATED WITH AUTOGRAFT + FIBERTAPE + HOOK PLATE.

  Patient problems: Failure of Implant

  MAUDE report 24531207 ↗
• MalfunctionNov 4, 2025Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 10/29/2025: THIS INCIDENT OCCURRED DURING AN AC JOINT REPAIR PROCEDURE ON (B)(6) 2025. THE ISSUE WAS IDENTIFIED WHEN THE SUTURE WAS SHUTTLED THROUGH THE BONE TUNNEL. THE CASE WAS DELAYED ABOUT FIVE MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465999 ↗
• InjurySep 16, 2025Break; Break

  IT WAS REPORTED THAT THE TIGHROPE BROKE POST OPERATIVELY. IT WAS FURTHER REPORTED THAT A REVISION SURGERY IS PLANNED. NO FURTHER INFORMATION RECEIVED. UPDATE 10-SEP-2025: ITS UNCLEAR WHEN THE INITIAL SURGERY WAS PERFORMED. HOWEVER, IT WAS FURTHER REPORTED THAT THE POST OPERATIVE COMPLIANCE WAS NOT FOLLOWED PROPERLY. THE REVISION SURGERY WAS ALREADY PERFORMED WITH A DEVICE FROM A COMPETITOR.

  Patient problems: Failure of Implant

  MAUDE report 23067174 ↗
• MalfunctionAug 5, 2025Positioning Failure; Failure to Advance; Positioning Failure; Failure to Advance

  ON 07/16/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2371-BL KNOTLESS AC TIGHTROPE REPAIR SYSTEM FAILED TO TENSION PROPERLY. THE TIGHTROPE HUNG APPROXIMATELY 1 INCH FROM THE BONE, RESULTING IN A COMPLETELY LOOSE CONSTRUCT. THE IMPLANT WAS CUT AND REPLACED WITH AN ADDITIONAL AR-2371-BL TIGHTROPE TO COMPLETE THE PROCEDURE, WHICH FUNCTIONED CORRECTLY USING THE SAME SURGICAL STEPS. THIS WAS DISCOVERED DURING AN AC JOINT RECONSTRUCTION PROCEDURE ON (B)(6) 2025, WITH NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 07/23/2025: THE CASE WAS DELAYED 10-15 MINUTES, WITH ADDITIONAL ANESTHESIA ADMINISTERED DURING THAT TIME FRAME. NO ADVERSE EFFECTS REPORTED ON OR AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720337 ↗
• InjuryJul 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 6/30/2025, A PATIENT REPORTED VIA PHONE CONCERNS REGARDING POST-OPERATIVE OUTCOMES FOLLOWING A PROCEDURE PERFORMED ON (B)(6) 2024. THE ORIGINAL SURGERY ADDRESSED A COMPLETE RUPTURE OF THE LIGAMENT IN THE AC JOINT, USING THE TIGHTROPE AC DOG BONE TECHNIQUE REINFORCED WITH AN ALLOGRAFT. APPROXIMATELY SIX WEEKS INTO POST-OPERATIVE REHABILITATION, THE PATIENT OBSERVED THAT THE COLLARBONE HAD BEGUN TO REEMERGE, MOVING UPWARD AT THE JOINT, MORE PROMINENTLY THAN ANTICIPATED. ALTHOUGH THE PATIENT REPORTED NO PAIN, THE PATIENT EXPERIENCED DISCOMFORT WHEN REACHING. REHABILITATION HAS PROVIDED IMPROVEMENT IN RANGE OF MOTION. FOLLOWING THE ONSET OF SYMPTOMS, THE PATIENT SOUGHT A SECOND MEDICAL OPINION AND UNDERWENT EXTENSIVE DIAGNOSTIC TESTING. ULTIMATELY, BOTH THE ORIGINAL SURGEON AND THE CONSULTED SPECIALIST CONCLUDED THAT REVISION SURGERY IS NOT RECOMMENDED, DUE TO THE POTENTIAL FOR INCREASED DAMAGE AND MOTION RESTRICTION. IT WAS ULTIMATELY CONSIDERED A COSMETIC ISSUE. ADDITIONAL INFORMATION RECEIVED ON 7/8/2025: THE ORIGINAL SURGEON NOTED ON (B)(6) 2024 THAT IMAGING SHOWED ¿STABLE CC RECONSTRUCTION WITH DOGBONE WITH INCREASED PROXIMAL DISPLACEMENT OF DISTAL CLAVICLE. ON (B)(6) 2025, THE

  Patient problems: Joint Dislocation; Loss of Range of Motion; Pain

  MAUDE report 22669738 ↗
• MalfunctionMay 12, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 05/14/2025: THIS OCCURRED DURING AN AC JOINT RECONSTRUCTION PROCEDURE ON (B)(6) 2025. ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. ANOTHER AR-2371BL KNOTLESS AC TIGHTROPE REPAIR SYSTEM WAS USED TO COMPLETE THE CASE. THE PROCEDURE PROCEEDED WITHOUT DELAY, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED ON OR AFTER THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001686 ↗
• MalfunctionMay 1, 2025Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED ON 05/26/2025: THIS ISSUE OCCURRED DURING AN AC JOINT RECONSTRUCTION PROCEDURE ON (B)(6) 2025; ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. TO COMPLETE THE CASE, ANOTHER AR-2371BL WAS UTILIZED. NO CASE DELAY WAS REPORTED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO INSTRUMENTS WERE USED TO PREPARE THE BONE SOCKET FOR IMPLANT INSERTION. THE PATIENT'S BONE QUALITY WAS AVERAGE, AND NO ADVERSE EFFECTS OR SIGNIFICANT DAMAGE WERE OBSERVED FOLLOWING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942991 ↗
• MalfunctionSep 20, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A DAC SURGERY IT WAS FOUND THAT THE DRILL HAD NO CANNULATION WHEN THE SURGEON TRIED TO OPEN THE DRILL IN ORDER TO INSERT THE NITINOL WIRE. THE SURGERY AS CHANGED AND FINISHED WITH A TIGERSTICK (AR-7209T) IN ORDER TO REPLACE THE CANNULATED DRILL. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20270632 ↗
• InjuryMar 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 3/4/2024, IT WAS REPORTED BY A PATIENT VIA PHONE THAT AN (B)(6) KNOTLESS AC TIGHTROPE REPAIR SYSTEM WAS IMPLANTED ON (B)(6) 2024. THE PATIENT IS NOW EXPERIENCING PAIN, AND THE CLAVICLE FEELS LIKE IT DID BEFORE THE SURGERY. THE PATIENT HAS AN UPCOMING APPOINTMENT WITH THE SURGEON TO SEE WHAT COULD HAVE GONE WRONG.

  Patient problems: Pain

  MAUDE report 18951310 ↗
• MalfunctionFeb 16, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN AC DOG BONE SURGERY THE WIRE BECAME STUCK INSIDE THE DRILL GUIDE. 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 18727625 ↗
• MalfunctionOct 13, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC AC JOINT SURGERY THE DRILL BROKE OFF. THE BROKEN PIECE WAS RETRIEVED OUT OF THE PATIENT. THERE WAS NO REPORTED 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 17929651 ↗