Arthrex® AR-3740SP-1Recalls & reported problems
Arthrex, Inc. · Dbl Loaded Knotless FTAK, Knee 1-Pack · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867428058), received between Nov 4, 2025 and Aug 24, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Unraveled Material2
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2026Unraveled Material
Patient problems: Insufficient Information
MAUDE report 50408217 ↗MalfunctionAug 24, 2026Unraveled Material
Patient problems: Insufficient Information
MAUDE report 50407870 ↗MalfunctionJul 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50100546 ↗MalfunctionJul 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50100512 ↗MalfunctionFeb 10, 2026Break
ON 21 JANUARY 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3740SP-1, DBL LOADED KNOTLESS FTAK KNEE 1-PACK WAS REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON 21 JANUARY 2025 DURING A LATERAL EXTRA-ARTICULAR TENODESIS. IT WAS REPORTED THAT WHILST UNDERTAKING LATERAL EXTRA-ARTICULAR TENODESIS PROCEDURE, THE SURGEON USED AR-3710 TO DRILL A HOLE FOR AR-3740SP-1 ANCHOR WHICH WAS IMPLANTED. AFTER THE ILIOTIBIAL BAND WAS PASSED THROUGH THE KNOTLESS LOOPS OF THE ANCHOR, THE FIRST BLACK COLOURED SUTURE LIMB WAS TENSIONED HOWEVER DURING TENSIONING THE LIMB WHICH WAS BEING PULLED SNAPPED OFF IN THE SURGEON'S HAND. MEANING THAT THE FIRST ANCHOR LOOP COULD NOT BE FULLY CINCHED. THE CASE WAS COMPLETED SUCCESSFULLY USING ONLY 1 OF THE 2 KNOTLESS LOOPS TO TIE DOWN THE ILIOTIBIAL BAND. THERE WAS CASE INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 24303101 ↗MalfunctionNov 4, 2025Break; Break
ON 10/27/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT ONE OF THE FORK-LIKE TIPS ON THE AR-3740SP-1 DOUBLE LOADED KNOTLESS KNEE FIBERTAK INSERTER WAS MISSING WHEN THE INSERTION HANDLE WAS REMOVED. THIS WAS DISCOVERED DURING A LET PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 10/30/2025: THE ANCHOR REMAINED IN THE PATIENT FOLLOWING THE PROCEDURE. A SINGLE PRONG FROM THE TIP OF THE ANCHOR INSERTER ALSO REMAINED INSIDE THE PATIENT. DESPITE THIS, THE CASE WAS COMPLETED AS PLANNED WITHOUT ANY COMPLICATIONS OR DELAYS USING A NEW AR-3740SP-1 DOUBLE LOADED KNOTLESS KNEE FIBERTAK. THERE WAS NO DELAY IN SURGERY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 23466475 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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