Arthrex® AR-1288QIS-80Recalls & reported problems
Arthrex, Inc. · QuadLink Implant System, 8MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867344730), received between Sep 12, 2024 and Sep 12, 2024 — classified as 1 malfunction.
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
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE TIGHTROPE FROM AN AR-1288QIS-80 QUADLINK IMPLANT SYSTEM BROKE WHEN THE BUTTON WAS REDUCED ON THE TIBIAL FIXATION. THE SURGEON HEARD SOMETHING POP, BUT BECAUSE THE GRAFT WAS INSIDE THE TUNNEL THE SURGEON DID NOT HAVE A VISUAL. HOWEVER, IT APPEARED THAT A STRAND OF THE TIGHTROPE HAD SNAPPED. THE SURGEON THREW ADDITIONAL SUTURES THROUGH THE GRAFT AND TIED IT OVER A POST AND WASHER TO COMPLETE THE CASE. NOTHING WAS REMOVED FROM THE PATIENT. THE TIGHTROPE FROM THE QUADLINK IMPLANT SYSTEM WAS STILL USED. THIS WAS DISCOVERED DURING A RIGHT ARTHROSCOPIC ACLR PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED FORTY-FIVE MINUTES AND ADDITIONAL ANESTHESIA WAS ADMINISTERED.
Patient problems: Foreign Body In Patient
MAUDE report 20204101 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
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- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- 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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