Arthrex® AR-1288QTT-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867473638), received between Dec 29, 2025 and Mar 18, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Positioning Failure; Device Dislodged or Dislocated

  ON (B)(6) 2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1288QTT-100 TIBIAL TUNNEL QUADLINK KIT EXPERIENCED AN ISSUE DURING USE. THIS WAS DISCOVERED DURING AN AUTOGRAFT ACL RECONSTRUCTION WITH QUAD TENDON PROCEDURE ON (B)(6) 2026. AFTER THE AUTOGRAFT QUAD TENDON WAS SHUTTLED, THE 17 MM ABS BUTTON WAS ATTACHED. WHILE TENSIONING THE TIBIAL SIDE, THE FIBERTAG TIGHTROPE II FAILED, CAUSING THE GRAFT TO SLIP BACK INTO THE JOINT AND SUBSEQUENTLY INTO THE TIBIAL TUNNEL. THE GRAFT WAS REMOVED, THE FIBERTAG TIGHTROPE II WAS CUT OUT, AND A NEW DEVICE WAS ATTACHED. THE GRAFT WAS THEN SHUTTLED, IMPLANTED, AND TENSIONED SUCCESSFULLY ON THE SECOND ATTEMPT USING A NEW AR-1588RTT2 FIBERTAG TIGHTROPE II. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 06-MAR-2026: THIS OCCURRED IN THE PATIENT AND DELAYED THE CASE BY 10 MINUTES. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625729 ↗
• MalfunctionDec 29, 2025Break; Break

  ON 08-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1288QTT-100 TIBIAL TUNNEL QUADLINK KIT (10 MM) SNAPPED WHILE ATTEMPTING TO SHORTEN THE FEMORAL FIBERTAG TIGHTROPE. THE GRAFT MAY HAVE BOTTOMED OUT, BUT NO EXCESSIVE FORCE WAS BELIEVED TO HAVE BEEN APPLIED. THE RUPTURE OCCURRED AT THE SPLICE WHERE THE FOUR TIGHTROPE SUTURES CONVERGE, RESULTING IN LOSS OF SUSPENSORY FIXATION. THE GRAFT AND BROKEN TIGHTROPE PORTION WERE REMOVED, AND A BTB TIGHTROPE WAS PASSED INTO THE FIBERTAG WHIPSTITCH TO COMPLETE THE PROCEDURE. THE EVENT PROLONGED SURGERY BY APPROXIMATELY 10 MINUTES, REQUIRING ADDITIONAL ANESTHESIA. THE ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2025. ADDITIONAL INFORMATION WAS RECEIVED ON 12/15/2025: THIS OCCURRED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED USING AN AR-1588BTB-IB TIGHTROPE II BTB. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908221 ↗