Arthrex® AR-1288QT-100Recalls & reported problems
Arthrex, Inc. · ACL FiberTag® TightRope® Implant System · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867344716), received between Aug 18, 2023 and Aug 27, 2026 — classified as 3 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Dull, Blunt1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Dull, Blunt
On (b)(6) 2026, it was reported by a sales representative via email that an AR-1288QT-100 ACL FiberTag TightRope was associated with a dull cutting instrument during graft harvest. It was reported that the instrument felt dull when cutting the tendon, resulting in premature cutting of the tendon. The procedure was completed successfully with no pieces breaking off in the patient. This occurred during a Quad ACL Autograft Reconstruction procedure performed on (b)(6) 2026.
Patient problems: Insufficient Information
MAUDE report 50474875 ↗MalfunctionOct 2, 2024Break; Break
ON 09/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE HARVESTER FROM AN AR-1288QT-100 ACL FIBERTAG TIGHTROPE IMPLANT SYSTEM BROKE WHILE INITIATING THE GRAFT HARVEST. ALL THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS COMPLETED USING AN AR-2386-10 QUADPRO HARVESTER. THE CASE WAS DELAYED ABOUT THIRTY SECONDS AND NO ADDITIONAL ANESTHESIA WAS NEEDED. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A QUAD AUTO ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20353418 ↗MalfunctionAug 18, 2023Material Separation; Material Separation
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1288QT-100 ACL FIBERTAGS SUTURE DISASSOCIATED FROM THE NEEDLE. THIS OCCURRED DURING AN ACL RECONSTRUCTION ON (B)(6) 2023, NO FRAGMENTS ENTERED THE PATIENT AND THE WAS A SLIGHT DELAY WHILE SWITCHING TO ANOTHER AR-1288QT-100 TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17577716 ↗
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- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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