Arthrex® AR-1288QAI-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867473584), received between Mar 20, 2026 and Jul 29, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Dull, Blunt

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50068995 ↗
• MalfunctionApr 1, 2026Break

  ON 12-MAR-2026, A FACILITY REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1288QAI-90 FINAL TENSIONING, THE QUAD TIGHT ROPE BROKE DURING FINAL TENSION. GRAFT HAD TO BE REMOVED AND REPLACED, NO PATIENT HARM. APPROXIMATELY 20¿30-MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755759 ↗
• MalfunctionMar 25, 2026Material Split, Cut or Torn

  ON 05-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1288QAI-90 ALL-INSIDE QUADLINK KIT EXPERIENCED A FIBERTAG TIGHTROPE FAILURE. THE ISSUE WAS IDENTIFIED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2026. THERE WAS NO REPORTED PATIENT HARM, AND THE SURGERY WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED ON 11-MAR-2026: THE ISSUE OCCURRED INSIDE THE PATIENT DURING GRAFT TENSIONING INTO THE FEMORAL TUNNEL. AS TENSION WAS APPLIED, THE SUTURE FRAYED AND RIPPED OFF THE METAL BUTTON, RESULTING IN FAILURE OF THE DEVICE. ALL DETACHED FRAGMENTS WERE ACCOUNTED FOR AND RETRIEVED FROM THE PATIENT DURING THE PROCEDURE. THE CASE WAS COMPLETED USING AN AR-1588BTB-IB TIGHTROPE II BTB. THE INCIDENT CAUSED A BRIEF DELAY OF APPROXIMATELY 5¿10 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689429 ↗
• MalfunctionMar 20, 2026Material Split, Cut or Torn

  ON (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1288QAI-90 ALL-INSIDE QUADLINK KIT, 9 MM, EXPERIENCED AN ISSUE DURING AN ARTHROSCOPIC-AIDED ACL RECONSTRUCTION PROCEDURE. AT THE FINAL STAGE OF ALL-INSIDE QUAD ACL RECONSTRUCTION, THE SUTURE ON THE FEMORAL TIGHTROPE SNAPPED, RENDERING THE IMPLANT NONFUNCTIONAL. THE GRAFT HAD BEEN SHUTTLED INTO THE JOINT, THE FEMORAL BUTTON WAS FLIPPED ON THE CORTEX, AND THE TIGHTROPE WAS PROVISIONALLY TENSIONED TO DRAW THE GRAFT INTO THE FEMORAL SOCKET. ONCE APPROXIMATELY 10 MM OF GRAFT WAS WITHIN THE FEMORAL SOCKET, THE TIBIAL SIDE WAS PROVISIONALLY TENSIONED UNTIL APPROXIMATELY 15 MM OF GRAFT WAS SEATED WITHIN THE TIBIAL TUNNEL. AT THAT POINT, THE SURGEON REMOVED THE SCOPE AND RETURNED TO THE FEMORAL TIGHTROPE TO COMPLETE FINAL TENSIONING. WHILE PULLING THE WHITE SUTURES INDIVIDUALLY, THE TIGHTROPE SNAPPED. ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED BY REMOVING THE GRAFT FROM THE JOINT AND APPLYING NEW AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANTS TO THE GRAFT. THE GRAFT WAS THEN REINSERTED, AND THE PROCEDURE WAS COMPLETED. A CASE DELAY OF APPROXIMATELY THIRTY MINUTES, WITH ADDITIONAL ANESTHESIA ADMINISTERED, OCCURRED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650853 ↗