Arthrex® AR-1589RTRecalls & reported problems
Arthrex, Inc. · TIGHTROPE BUTTON EXTENDER · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867019812), received between Jun 20, 2022 and Apr 24, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 3/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588BTB-2J TIGHTROPE II BTB GOT SUCK AND WOULD NOT ADVANCE. THE SURGEON USED AN AR-1589RT TIGHTROPE BUTTON, AND THE BUTTON CAME DISLODGED AFTER PASSING THE FAR CORTEX OF THE FEMUR. GETTING THE BUTTON RESEATED MIGHT HAVE CAUSED THE TIGHTROPE II BTB TO GET TANGLED. THE TIGHTROPE II BTB WAS CUT, AND ANOTHER ONE WAS USED TO PROCEED WITH THE PROCEDURE. THE SURGEON ENDED UP DRILLING A NEW 4 MM HOLE AND DID NOT NEED TO USE THE AR-1589RT TIGHTROPE BUTTON. THIS WAS DISCOVERED DURING AN ACL REPAIR PROCEDURE ON (B)(6) 2024.
Patient problems: Insufficient Information
MAUDE report 19175439 ↗MalfunctionJun 20, 2022Detachment of Device or Device Component
ON (B)(6) 2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1589RT TIGHTROPE BUTTON EXTENDER DISENGAGED FROM THE TIGHTROPE AT SOME POINT BETWEEN THE PROCEDURE AND THE POST OPERATIVE. THE CASE WAS COMPLETED SUCCESSFULLY AND THE BUTTON REMAINS INSIDE THE PATIENT WITHOUT ISSUES. THIS WAS DISCOVERED DURING A POST OPERATIVE X-RAY FROM AN ACL PROCEDURE. SURGEON DOES NOT THINK THAT PATIENT WILL REQUIRE A REVISION SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 14742797 ↗
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- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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