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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867473553), received between Jun 24, 2025 and Mar 12, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionMar 12, 2026Break

  ON (B)(6), A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE TIGHTROPE CONSTRUCT ON THE FEMORAL SIDE FROM AR-1288QAI-100 ALL-INSIDE QUADLINK KIT BROKE DURING THE PROCEDURE. THE CASE WAS CONTINUED USING A REPLACEMENT AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT, WHICH ALSO BROKE. A SECOND AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT FROM THE SAME LOT WAS THEN OPENED AND FUNCTIONED WITHOUT ISSUE. THE EVENT OCCURRED INTRAOPERATIVELY ON (B)(6), WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6): IT WAS REPORTED THAT AN AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT DEVICE BROKE WHILE PULLING THE TIGHTROPE THROUGH THE FEMORAL TUNNEL AND TENSIONING IT DOWN DURING AN ACL RECONSTRUCTION PROCEDURE. THE BREAK OCCURRED INSIDE THE PATIENT. BOTH IMPLANTS THAT BROKE WERE REMOVED, AND ANOTHER TIGHTROPE WAS IMPLANTED ON THE FEMORAL SIDE. THE FEMORAL SIDE HAD TO BE REDONE TWICE, RESULTING IN AN APPROXIMATE 15-MINUTE SURGICAL DELAY. NO ADDITIONAL ANESTHESIA INFORMATION WAS REPORTED, OTHER THAN THE DELAY TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING OR FOLLOWING THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578951 ↗
• MalfunctionJan 12, 2026Positioning Failure

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1288QAI-100 ALL-INSIDE QUADLINK KIT (10 MM) FAILED TO TENSION PROPERLY. THE TIGHTROPE MECHANISM APPEARED TO ¿GIVE OUT¿ WHILE ATTEMPTING TO SEAT THE GRAFT IN THE FEMORAL TUNNEL AND COULD NOT SUSPEND THE GRAFT USING THE TENSIONING TAILS. THE AUTOGRAFT WAS THEN REMOVED, AND THE DEFECTIVE TIGHTROPE WAS CUT OUT AND REPLACED WITH AN AR-1588BTB-IB TIGHTROPE II BTB, WHICH FUNCTIONED AS INTENDED. THE CASE WAS DELAYED, AND ADDITIONAL ANESTHESIA WAS LIKELY ADMINISTERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ISSUE OCCURRED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 29-DEC-2025: THE PROCEDURE WAS DELAYED BY APPROXIMATELY 30 MINUTES, AND THE AMOUNT OF ADDITIONAL ANESTHESIA ADMINISTERED IS UNKNOWN. THE ISSUE WITH THE TIGHTROPE IMPLANT WAS FIRST IDENTIFIED WHEN THE BUTTON WAS CONFIRMED TO BE FLIPPED, AND THE GRAFT WAS BEING TENSIONED ON THE FEMORAL SIDE. AT THAT POINT, THE IMPLANT FAILED. THERE WAS NO FRAYING OF THE TENSIONING TAILS DURING THE EVENT. THE CONSTANT UNLOADING OCCURRED SUDDENLY. NO FRAGMENTS REMAINED INSIDE THE PATIENT; ALL COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036176 ↗
• MalfunctionDec 8, 2025Break; Break

  ON 11/17/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1288QAI-100 QUAD LINKS FLIP CUTTER BROKE DURING USE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE BROKEN PIECE WAS RETRIEVED WITHOUT ISSUES. ANOTHER KIT WAS OPENED, AND THE FLIP CUTTER WAS USED WITHOUT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742088 ↗
• MalfunctionJun 24, 2025Break; Positioning Failure; Break; Positioning Failure

  ON 06/03/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE FIBERTAG TIGHTROPE II WITH INTERNALBRACE, INCLUDED IN AN AR-1288QAI-100 ALL-INSIDE QUADLINK KIT, DID NOT PROPERLY TENSION THE GRAFT INTO THE FEMORAL TUNNEL. THE ISSUE WAS IDENTIFIED DURING AN ACLR PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22317743 ↗