Arthrex® AR-1588RT2-IBSRecalls & reported problems
Arthrex, Inc. · ImplSys,T-RpII,RT-IB,Drill,FbrLink · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867428515), received between Mar 24, 2025 and May 6, 2025 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Device Dislodged or Dislocated2
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 04/07/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1588RT2-IBS IMPLANT SYSTEM, TIGHTROPE II RT-IB, WITH TIGHTROPE PIN 4 MM AND FIBERLINK SUTURE #2, HAD A TIGHTROPE THAT WOULD NOT LOOSEN OR TIGHTEN ON ONE SIDE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21968709 ↗MalfunctionMar 24, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
ON 03/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588RT2-IBS IMPLANT SYSTEM BROKE AT THE KNOTLESS MECHANISM. THIS OCCURRED DURING AN ACL RECONSTRUCTION ON (B)(6) 2025, WHEN TENSIONING THE TIGHTROPE AND PULLING THE GRAFT INTO THE SOCKET IT BROKE AT THE KNOTLESS MECHANISM. THE FRAGMENTS WERE ALL RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-1588RT2-IBS. THERE WAS NO HARM ON THE PATIENT. THERE WAS ABOUT A 15 MINUTE DELAY AND IT IS UNKNOWN IF ADDITIONAL WAS ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21679007 ↗MalfunctionMar 24, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
ON 03/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588RT2-IBS IMPLANT SYSTEM BROKE AT THE KNOTLESS MECHANISM. THIS OCCURRED DURING A ACL RECONSTRUCTION ON (B)(6) 2025 WHEN TENSIONING THE TIGHTROPE AND PULLING THE GRAFT INTO THE SOCKET IT BROKE AT THE KNOTLESS MECHANISM. THE FRAGMENTS WERE ALL RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-1588RT2-IBS. THERE WAS NO HARM ON THE PATIENT. THERE WAS ABOUT A 15 MINUTE DELAY AND IT IS UNKNOW IF ADDITIONAL WAS ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21678614 ↗MalfunctionMar 24, 2025Break; Break
ON (B)(6)2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588RT2-IBS IMPLANT SYSTEM BROKE AT THE KNOTLESS MECHANISM. THIS OCCURRED DURING A ACL RECONSTRUCTION ON (B)(6)2025 WHEN TENSIONING THE TIGHTROPE AND PULLING THE GRAFT INTO THE SOCKET IT BROKE AT THE KNOTLESS MECHANISM. THE FRAGMENTS WERE ALL RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-1588RT2-IBS. THERE WAS NO HARM ON THE PATIENT. THERE WAS ABOUT A 15 MINUTE DELAY AND IT IS UNKNOW IF ADDITIONAL WAS ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21677665 ↗
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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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