Arthrex® AR-2600FSB-3Recalls & reported problems
Arthrex, Inc. · FBRTK SPDBRG IMP SYS W/ BC SWVLK · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867429871), received between Jun 5, 2024 and Oct 27, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Material Frayed1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2025Material Frayed; Material Frayed
ON 10/03/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2600FSB-3 FBRTK SPDBRG FIBER TAPE SUTURE WAS FRAYED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED FROM REP ON 10/09/25. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2025. ONE KIT WAS USED AND THIS OCCURRED DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME PART NUMBER. THERE WAS NO DELAY IN SURGERY AND NO ADDITIONAL ANESTHESIA WAS USED. THE DEVICE IS NOT AVAILABLE FOR RETURN, AND NO PHOTOS WERE TAKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23389501 ↗InjuryJun 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE FIBERTAKS FROM AN AR-2600FSB-3 FIBERTAK SPEED BRIDGE IMPLANT SYSTEM PULLED OUT; THE ANCHORS DID NOT BUNCH UP. THE CASE WAS COMPLETED USING A SWIVELOCK. THIS WAS DISCOVERED DURING A REVISION RCR PROCEDURE ON (B)(6) 2024. THE ORIGINAL RCR PROCEDURE WAS PERFORMED ON (B)(6) 2024. BOTH SURGERIES WERE PERFORMED BY THE SAME SURGEON AND AT THE SAME FACILITY. IN THE ORIGINAL PROCEDURE, THREE MEDIAL-ROW SWIVELOCKS AND THREE LATERAL-ROW SWIVELOCKS WERE IMPLANTED. NOTHING WAS EXPLANTED DURING THE REVISION.
Patient problems: Insufficient Information
MAUDE report 19466239 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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