Arthrex® AR-1288QIS-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867344761), received between Apr 28, 2023 and Dec 3, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Break; Break

  ON 11/13/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT THE TIP OF AN AR-1204FF FLIPCUTTER III DRILL AND AN AR-1204FF FLIPCUTTER III DRILL FROM THE AR-1288QIS-110 QUADLINK IMPLANT SYSTEM BROKE OFF INSIDE THE PATIENT'S KNEE. THE BROKEN PIECES WERE RETRIEVED. THIS OCCURRED DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) RECONSTRUCTION PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 11/19/2025: BOTH ISSUES OCCURRED DURING THE REMOVAL OF THE DEVICES FROM THE BONE, AND ALL DETACHED FRAGMENTS WERE RETRIEVED. THE CASE WAS DELAYED BY APPROXIMATELY ONE TO TWO MINUTES WHILE ANOTHER PRODUCT WAS OPENED. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO SPECIFIC DETAILS REGARDING BONE PREPARATION OR BONE QUALITY WERE DOCUMENTED.

  Patient problems: Insufficient Information

  MAUDE report 23705335 ↗
• MalfunctionMar 13, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-1288QIS-110 QUADLINK IMPLANT SYSTEMS TIP BROKE. THIS OCCURRED DURING WHEN THE DEVICE BROKE IN THE JOINT.

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

  MAUDE report 21596225 ↗
• MalfunctionJun 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 03/17/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA PHONE THAT AN AR-1288QIS-110 QUADLINK IMPLANT SYSTEMS TIGHTROPE HAD A SUTURE THAT WAS UNLOADED. THIS OCCURRED DURING AN ACL RECONSTRUCTION, THE DEVICE WAS NOT USED. AN AR-1588TN-21 TIGHTROPE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533004 ↗
• MalfunctionSep 8, 2023Unintended Movement; Unintended Movement

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1288QIS-110 QUADLINK IMPLANT SYSTEMS FLIPCUTTER WOBBLED WHEN THEY RAN THE DRILL. THEY ATTEMPTED A SECOND TIME AND IT STILL APPEARED TO WOBBLE. THIS OCCURRED DURING AN ACL RECONSTRUCTION, AN AR-1204FF WAS OPENED AND THE CASE WAS COMPLETED WITHOUT ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 17710167 ↗
• MalfunctionApr 28, 2023Break; Break

  ON 3/31/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A FLIPCUTTER III FROM AN AR-1288QIS-110 QUADLINK IMPLANT SYSTEM BROKE DURING USE. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2023. CASE WAS COMPLETED USING AN AR-1288RTT-FC3 FIBERTAG TIGHTROPE WITH FLIPCUTTER III. ALL BROKEN PIECES WERE RETRIEVED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16838829 ↗