Arthrex® AR-3631-1Recalls & reported problems
Arthrex, Inc. · FiberTak, TripLoad FW BL/W, BLK/W, W · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867276895), received between Feb 26, 2025 and Oct 15, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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
- Detachment of Device or Device Component2
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON 10/08/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT (B)(4) AR-3631-1 FIBERTAK TRIPLE-LOADED SUTURE ANCHORS DETACHED FROM THE GREATER TUBEROSITY DURING A SHOULDER ARTHROSCOPY. THE TECHNIQUE WAS CORRECTLY PERFORMED. ONE OF THE ANCHORS HAD ITS SUTURE COMPLETELY DAMAGED. AN ADDITIONAL ANCHOR WAS USED AND INSERTED AFTER DRILLING A NEW HOLE WITH THE FIBERTAK CUFF DRILL AND GUIDE. NO PATIENT WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23300575 ↗MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON 10/08/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT (QTY. 2) AR-3631-1 FIBERTAK TRIPLE-LOADED SUTURE ANCHORS DETACHED FROM THE GREATER TUBEROSITY DURING A SHOULDER ARTHROSCOPY. THE TECHNIQUE WAS CORRECTLY PERFORMED. ONE OF THE ANCHORS HAD ITS SUTURE COMPLETELY DAMAGED. AN ADDITIONAL ANCHOR WAS USED AND INSERTED AFTER DRILLING A NEW HOLE WITH THE FIBERTAK CUFF DRILL AND GUIDE. NO PATIENT WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23300480 ↗MalfunctionFeb 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 02/14/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-3631-1 FIBERTAK¿ RC SUTURE ANCHOR LOOSENED. THIS OCCURRED DURING USE THEY FOLLOWED ALL THE STEPS OF THE TECHNIQUE. DURING SUTURING, THE ANCHOR LOOSENED AND ANOTHER ANCHOR HAD TO BE OPENED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21468744 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
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- 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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