Arthrex® AR-1288RTT2-IBSRecalls & reported problems
Arthrex, Inc. · ImplSys,FT T-RpII,RTT-IB,Drill,FbrLink · Class 2 · Implant
Data updated Oct 18, 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 00888867430358), received between Dec 22, 2025 and Jan 26, 2026 — classified as 2 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
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2026Break
ON 09-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE TIGHTROPE SUTURES ON AN AR-1288RTT2-IBS FIBERTAG TIGHTROPE II WITH INTERNALBRACE BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 19-JAN-2026: DURING AN ACL RECONSTRUCTION PROCEDURE, THE TIGHTROPE SUTURES ON AN AR-1288RTT2-IBS FIBERTAG TIGHTROPE II BROKE WHILE SHUTTLING THE GRAFT. THE BROKEN TIGHTROPE WAS REMOVED FROM THE PATIENT, AND THE CASE WAS COMPLETED USING AN AR-1588BTB-2J TIGHTROPE II BTB. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 10 MINUTES, DURING WHICH ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24177507 ↗MalfunctionDec 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ON 12/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1288RTT2-IBS AND AN AR-3780SP MALFUNCTIONED DURING THE CASE. THE TIGHTROPE FEATURE OF THE PRODUCT AR-1288RTT2-IBS RIPPED DURING TENSIONING OF THE GRAFT INTO THE FEMORAL TUNNEL. THE GRAFT HAD TO BE PULLED OUT AND RE-PREPPED USING PRODUCT: AR-1588RTT2-IB. DURING THE SAME CASE, ONE OF THE SUTURE LIMBS OF PRODUCT: AR-3780SP TORE OFF, RENDERING THE IMPLANT UNUSABLE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865195 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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