Arthrex® AR-3740SPRecalls & reported problems
Arthrex, Inc. · Double Loaded Knotless FiberTak, Knee · Class 2 · Implant
Quick summary
This Arthrex Double Loaded Knotless FiberTak knee anchor is a soft-tissue fixation implant. Reports describe anchors breaking or dislodging during procedures, sometimes leaving small fragments behind; 22 mention foreign body. There are 93 adverse event reports, 2 injuries, 91 malfunctions, no deaths, and no recalls name this device identifier. Last 12 months had 36 reports, compared with 26 the prior year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 93
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00888867428041), received between Sep 11, 2023 and Sep 8, 2026 — classified as 2 injuries, 91 malfunctions.
The most frequently reported specific device problem is “Break” (39 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break39
- Device Dislodged or Dislocated23
- Use of Device Problem6
- Positioning Failure5
- Failure to Advance4
- Material Split, Cut or Torn3
- Material Twisted/Bent3
- Patient Device Interaction Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions49
- Insufficient Information27
- Foreign Body In Patient22
- Failure of Implant2
- Hypersensitivity/Allergic reaction1
- Pain1
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Device Dislodged or Dislocated
On (b)(6) 2026, a sales representative reported via email that an AR-3740SP Double Loaded Knotless Knee FiberTak Anchor experienced an issue during use. The blue loop stitch was successfully converted; however, the black loop repeatedly cinched up too small, and the anchor pulled out of the bone on three separate attempts. Alternative fixation options were limited due to patient anatomy. The patient outcome was not reported.
Patient problems: Insufficient Information
MAUDE report 50666755 ↗MalfunctionAug 20, 2026Device Dislodged or Dislocated
Additional information was received on 19-Aug-2026: The implant came out after insertion while the anchor was being set. No damage was observed on the implant, sutures, or inserter prior to use. The procedure was delayed by a couple of minutes while a replacement implant was opened. The case was completed using another AR-3740SPR-3740SP Double Loaded Knotless FiberTak. No additional surgical intervention or anesthesia was required.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50344857 ↗MalfunctionJul 31, 2026Break
Patient problems: Foreign Body In Patient
MAUDE report 50105285 ↗MalfunctionJul 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50084720 ↗MalfunctionJul 27, 2026Break
Patient problems: Foreign Body In Patient
MAUDE report 50017823 ↗MalfunctionMay 12, 2026Break
ON 24TH APR 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AR-3740SP DOUBLE LOADED KNOTLESS FIBERTAK, KNEE BATCH 15437960 BROKE DURING INSERTION. THIS WAS DETECTED DURING LATERAL EXTRA-ARTICULAR TENODESIS PROCEDURE ON THE SAME DAY. A BROKEN FRAGMENT OF APPROXIMATELY 1 MM FROM THE IMPLANT HOLDER FORK REMAINED IN THE PATIENT DESPITE ATTEMPTS TO REMOVE IT USING AVAILABLE INSTRUMENTS. ADDITIONAL INFORMATION RECEIVED ON 5TH MAY 2026 INDICATES THAT AN AR-3710 DRILL SOCKET, BATCH NUMBER 15549638, WAS ALSO USED BY THE SURGEON DURING THIS SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 25148455 ↗MalfunctionMar 12, 2026Material Frayed; Device Dislodged or Dislocated
ON 16-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3740SP DOUBLE-LOADED KNOTLESS KNEE FIBERTAK ANCHOR EXPERIENCED AN ISSUE DURING USE. WHILE PASSING THE ANCHOR THROUGH THE GUIDE INSIDE THE PATIENT, THE ANCHOR WAS PULLED OUT, AND THE SUTURES WERE REATTACHED TO THE ANCHOR. WHEN THE DEVICE WAS REINSERTED THROUGH THE GUIDE, THE LOOP END AT THE BOTTOM OF THE ANCHOR WAS FOUND TO BE FRAYED AND DAMAGED. ALL COMPONENTS WERE REMOVED AND REPLACED WITH ANOTHER DEVICE OF THE SAME PART NUMBER. THE EVENT RESULTED IN LESS THAN A FIVE-MINUTE CASE DELAY, WITH UNKNOWN ADDITIONAL ANESTHESIA TIME. THIS ISSUE OCCURRED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24580413 ↗MalfunctionMar 5, 2026Material Twisted/Bent
ON 12-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT TWO AR-3740SP DOUBLE-LOADED KNOTLESS KNEE FIBERTAK ANCHORS EXPERIENCED ISSUES DURING A LET PROCEDURE PERFORMED ON (B)(6) 2026. ONE ANCHOR BROKE AT THE SELF-PUNCHING PORTION AT THE TIP OF THE INSERTER, AND THE BROKEN PIECES WERE NOT RETRIEVED. A SECOND ANCHOR WAS FOUND TO BE BENT. ALTHOUGH THE LOT NUMBERS FOR THE TWO ANCHORS ARE KNOWN, IT IS UNKNOWN WHICH LOT CORRESPONDS TO EACH AFFECTED DEVICE. A REPLACEMENT AR-3740SP ANCHOR WAS USED TO COMPLETE THE PROCEDURE. NO SIGNIFICANT PROCEDURAL DELAY OCCURRED, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 18-FEB-2026: THE SECOND ANCHOR WAS OBSERVED BENDING ON THE INSERTER. THERE WAS NO CONFIRMATION REGARDING WHICH LOT NUMBER THE RETAINED FRAGMENT ORIGINATED FROM. ALL THREE ANCHORS REMAIN IMPLANTED IN THE PATIENT.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 24519061 ↗MalfunctionMar 5, 2026Break
ON 12-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT TWO AR-3740SP DOUBLE-LOADED KNOTLESS KNEE FIBERTAK ANCHORS EXPERIENCED ISSUES DURING A LET PROCEDURE PERFORMED ON (B)(6) 2026. ONE ANCHOR BROKE AT THE SELF-PUNCHING PORTION AT THE TIP OF THE INSERTER, AND THE BROKEN PIECES WERE NOT RETRIEVED. A SECOND ANCHOR WAS FOUND TO BE BENT. ALTHOUGH THE LOT NUMBERS FOR THE TWO ANCHORS ARE KNOWN, IT IS UNKNOWN WHICH LOT CORRESPONDS TO EACH AFFECTED DEVICE. A REPLACEMENT AR-3740SP ANCHOR WAS USED TO COMPLETE THE PROCEDURE. NO SIGNIFICANT PROCEDURAL DELAY OCCURRED, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 18-FEB-2026: THE SECOND ANCHOR WAS OBSERVED BENDING ON THE INSERTER. THERE WAS NO CONFIRMATION REGARDING WHICH LOT NUMBER THE RETAINED FRAGMENT ORIGINATED FROM. ALL THREE ANCHORS REMAIN IMPLANTED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 24519059 ↗MalfunctionMar 3, 2026Positioning Failure
ON 11-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3740SP DOUBLE-LOADED KNOTLESS KNEE FIBERTAK ANCHOR WAS FOUND TO CONTAIN ONLY ONE FIXED PRECONSTRUCTED KNOTLESS LOOP. THE BLUE SUTURE WAS NOT SECURED WITHIN THE ANCHOR AND WAS FREELY SLIDING THROUGH THE MECHANISM. THE ISSUE WAS IDENTIFIED DURING A LET PROCEDURE ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 17-FEB-2026: THE ISSUE WAS DISCOVERED DURING IMPLANTATION. THE CASE WAS COMPLETED USING AN AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK. THE SURGEON ELECTED TO CONTINUE USING THE IMPLANTED ANCHOR AND TIED IN THE SUTURE RATHER THAN UTILIZING THE KNOTLESS MECHANISM. NO SURGICAL DELAY OCCURRED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.
Patient problems: Foreign Body In Patient
MAUDE report 24497307 ↗MalfunctionFeb 23, 2026Break
ON 05-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK EXPERIENCED AN ISSUE DURING USE. THE FORK-LIKE TIP BROKE UPON FIRST CONTACT WITH THE PATIENT¿S BONE. THIS ISSUE WAS DISCOVERED DURING A LET PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 11-FEB-2025: ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED WITH AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK ANCHOR. THE CASE WAS DELAYED FIVE MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.
Patient problems: Insufficient Information
MAUDE report 24417555 ↗MalfunctionFeb 18, 2026Positioning Failure
ON (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-3770SP HYBRID KNEE FIBERTAK® ANCHORS AND (2) AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK® ANCHORS BACKED OUT. THIS OCCURRED DURING AN MPFL RECONSTRUCTION ON (B)(6) 2026 WHEN ALL (4) DEVICES BACKED OUT OF THE PATIENT. THE PATIENT HAD VERY GOOD BONE QUALITY, WHICH WAS PREPPED USING AN AR-3712-29 2.9MM DRILL FOR KNEE FIBERTAKS. THESE FAILURES RESULTED IN A 15-MINUTE DELAY WHICH NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PROCEDURE WAS COMPLETED USING AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK® ANCHOR, AND AN AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK® ANCHOR. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24376533 ↗MalfunctionFeb 18, 2026Positioning Failure
ON 30-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-3770SP HYBRID KNEE FIBERTAK® ANCHORS AND (2) AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK® ANCHORS BACKED OUT. THIS OCCURRED DURING AN MPFL RECONSTRUCTION ON 30-JAN-2026 WHEN ALL (4) DEVICES BACKED OUT OF THE PATIENT. THE PATIENT HAD VERY GOOD BONE QUALITY, WHICH WAS PREPPED USING AN AR-3712-29 2.9MM DRILL FOR KNEE FIBERTAKS. THESE FAILURES RESULTED IN A 15-MINUTE DELAY WHICH NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PROCEDURE WAS COMPLETED USING AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK® ANCHOR, AND AN AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK® ANCHOR. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24376528 ↗MalfunctionFeb 16, 2026Break
IT WAS REPORTED THAT DURING A LATERAL EXTRA-ARTICULAR TENODESIS SURGERY IN THE KNEE THE TIP OF THE INSERTER BROKE OFF. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (SWIVELOCK). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24345406 ↗MalfunctionFeb 10, 2026Break
ON (B)(6) 2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT THREE AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK ANCHORS WERE INVOLVED IN AN INTRAOPERATIVE ISSUE DURING AN ACL RECONSTRUCTION WITH LET PROCEDURE ON (B)(6) 2026. DURING THE INSERTION OF THE FIRST ANCHOR, THE INSERTER BROKE, PREVENTING SUCCESSFUL PLACEMENT. A SECOND ANCHOR WAS THEN ATTEMPTED; HOWEVER, IT DID NOT SECURE WITHIN THE BONE TUNNEL AND SUBSEQUENTLY FELL OUT. A THIRD ANCHOR WAS OPENED FOR USE, BUT ITS INSERTER ALSO BROKE DURING INSERTION. DESPITE THIS, THE THIRD ANCHOR WAS SUCCESSFULLY IMPLANTED, AND THE SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE LOCATION OF THE BROKEN FRAGMENT OF THE INSERTER REMAINS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 26-JAN-2026: THE THREE AR-3740SP DOUBLE-LOADED KNOTLESS KNEE FIBERTAK ANCHORS WERE PLACED IN THE PATELLA SOCKET. FOR THE FIRST AND THIRD ANCHOR COMPLAINTS, THE INSERTER TIPS BROKE DURING USE, AND THE BROKEN FRAGMENTS WERE RETRIEVED FROM THE PATIENT IN BOTH INSTANCES. THE PROCEDURE EXPERIENCED A BRIEF DELAY OF APPROXIMATELY 15 MINUTES. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24308442 ↗MalfunctionFeb 10, 2026Break
ON 20-JAN-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT THREE AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK ANCHORS WERE INVOLVED IN AN INTRAOPERATIVE ISSUE DURING AN ACL RECONSTRUCTION WITH LET PROCEDURE ON (B)(6) 2026. DURING THE INSERTION OF THE FIRST ANCHOR, THE INSERTER BROKE, PREVENTING SUCCESSFUL PLACEMENT. A SECOND ANCHOR WAS THEN ATTEMPTED; HOWEVER, IT DID NOT SECURE WITHIN THE BONE TUNNEL AND SUBSEQUENTLY FELL OUT. A THIRD ANCHOR WAS OPENED FOR USE, BUT ITS INSERTER ALSO BROKE DURING INSERTION. DESPITE THIS, THE THIRD ANCHOR WAS SUCCESSFULLY IMPLANTED, AND THE SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE LOCATION OF THE BROKEN FRAGMENT OF THE INSERTER REMAINS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 26-JAN-2026: THE THREE AR-3740SP DOUBLE-LOADED KNOTLESS KNEE FIBERTAK ANCHORS WERE PLACED IN THE PATELLA SOCKET. FOR THE FIRST AND THIRD ANCHOR COMPLAINTS, THE INSERTER TIPS BROKE DURING USE, AND THE BROKEN FRAGMENTS WERE RETRIEVED FROM THE PATIENT IN BOTH INSTANCES. THE PROCEDURE EXPERIENCED A BRIEF DELAY OF APPROXIMATELY 15 MINUTES. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24308438 ↗MalfunctionFeb 10, 2026Failure to Advance
ON 20-JAN-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT THREE AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK ANCHORS WERE INVOLVED IN AN INTRAOPERATIVE ISSUE DURING AN ACL RECONSTRUCTION WITH LET PROCEDURE ON (B)(6) 2026. DURING THE INSERTION OF THE FIRST ANCHOR, THE INSERTER BROKE, PREVENTING SUCCESSFUL PLACEMENT. A SECOND ANCHOR WAS THEN ATTEMPTED; HOWEVER, IT DID NOT SECURE WITHIN THE BONE TUNNEL AND SUBSEQUENTLY FELL OUT. A THIRD ANCHOR WAS OPENED FOR USE, BUT ITS INSERTER ALSO BROKE DURING INSERTION. DESPITE THIS, THE THIRD ANCHOR WAS SUCCESSFULLY IMPLANTED, AND THE SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE LOCATION OF THE BROKEN FRAGMENT OF THE INSERTER REMAINS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 26-JAN-2026: THE THREE AR-3740SP DOUBLE-LOADED KNOTLESS KNEE FIBERTAK ANCHORS WERE PLACED IN THE PATELLA SOCKET. FOR THE FIRST AND THIRD ANCHOR COMPLAINTS, THE INSERTER TIPS BROKE DURING USE, AND THE BROKEN FRAGMENTS WERE RETRIEVED FROM THE PATIENT IN BOTH INSTANCES. THE PROCEDURE EXPERIENCED A BRIEF DELAY OF APPROXIMATELY 15 MINUTES. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24308437 ↗MalfunctionFeb 10, 2026Break
ON 22-JAN-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT WHEN THE SUTURES OF AN AR-3740SP SELF-PUNCHING 2.6 MM DOUBLE LOADED KNOTLESS KNEE FIBERTAK WERE PULLED, THE ANCHOR BROKE. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24306436 ↗MalfunctionFeb 10, 2026Break
ON 14-JAN-2026, A MONTHLY MAUDE DATABASE REVIEW IDENTIFIED A REPORT INVOLVING AN AR-3740SP KNEE DOUBLE LOADED KNOTLESS FIBERTAK ANCHOR THAT HAD NOT BEEN PREVIOUSLY REPORTED TO ARTHREX. ACCORDING TO THE MAUDE NARRATIVE, DURING SURGERY, THE SURGEON INSERTED THE SELF-PUNCHING ANCHOR USING THE INSERTER. UPON REMOVAL OF THE INSERTER FROM THE KNEE, THE TIP WAS NOTED TO BE MISSING. RADIOGRAPHS IDENTIFIED A SMALL FRAGMENT OF THE INSERTER, APPROXIMATELY 1¿2 MM IN SIZE, RETAINED IN THE PATIENT. THE SURGEON EXPLAINED THAT ATTEMPTING TO RETRIEVE THE RETAINED FOREIGN BODY COULD CAUSE ADDITIONAL DAMAGE AND THEREFORE RECOMMENDED LEAVING IT IN PLACE, AS IT IS NOT EXPECTED TO HARM THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 29-JAN-2026: THIS WAS DISCOVERED DURING A LEFT KNEE REVISION ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION AND LATERAL EXTRA-ARTICULAR TENODESIS. THE FIBERTAK ANCHOR WAS SUCCESSFULLY IMPLANTED, AND NO SURGICAL DELAYS WERE REPORTED. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA WITH THE ADDITION OF A NERVE BLOCK. ADDITIONAL INFORMATION WAS RECEIVED ON 5-FEB-2026: ACCORDING TO THE FACILITY REPRESENTATIVE, THE AR-3740SP KNEE DOUBLE LOADED KNOTLESS FIBERTAK ANCHOR BROKE D
Patient problems: Foreign Body In Patient
MAUDE report 24304494 ↗MalfunctionFeb 6, 2026Break
IT WAS REPORTED THAT DURING A LATERAL EXTRA-ARTICULAR TENODESIS SURGERY IN THE KNEE THE TIP OF THE INSERTER BROKE OFF ON INSERTION. THE BROKEN PART REMAINED IN THE PATIENT, SINCE IT WAS SECURELY EMBEDDED IN THE BONE. THE ANCHOR OF THE INSERTER WAS STILL DEPLOYED AND WAS USED SUCCESSFULLY TO FINISH THE SURGERY. THE SURGEON ALSO NOTED THAT THE PATIENT WASN'T STABLE AS HE MALLETED THE ANCHOR IN, THE KNEE MOVED WHICH PUT THE FORK TIPS UNDER EXCESSIVE FORCE RESULTING IN BREAKAGE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 24280809 ↗MalfunctionFeb 6, 2026Device Dislodged or Dislocated
ON 16-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK ANCHORS PULLED OUT DURING A LET KNEE PROCEDURE PERFORMED ON (B)(6) 2026. THE SURGICAL TEAM RELOCATED THE FIXATION SITES AND SUCCESSFULLY IMPLANTED AN ADDITIONAL AR-3740SP ANCHOR, WHICH HELD AS INTENDED. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED ON 20-JAN-2026. ADDITIONAL INFORMATION WAS RECEIVED ON 22-JAN-2026: THE PROCEDURE WAS DELAYED APPROXIMATELY 5¿10 MINUTES WHILE ATTEMPTS WERE MADE TO PLACE ADDITIONAL ANCHORS. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24278355 ↗MalfunctionFeb 6, 2026Device Dislodged or Dislocated
ON (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK ANCHORS PULLED OUT DURING A LET KNEE PROCEDURE PERFORMED ON (B)(6) 2026. THE SURGICAL TEAM RELOCATED THE FIXATION SITES AND SUCCESSFULLY IMPLANTED AN ADDITIONAL AR-3740SP ANCHOR, WHICH HELD AS INTENDED. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED ON 20-JAN-2026. ADDITIONAL INFORMATION WAS RECEIVED ON 22-JAN-2026: THE PROCEDURE WAS DELAYED APPROXIMATELY 5¿10 MINUTES WHILE ATTEMPTS WERE MADE TO PLACE ADDITIONAL ANCHORS. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24278145 ↗MalfunctionFeb 4, 2026Break
ON 14-JAN-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK ANCHOR WAS INSERTED, AND THE TIP OF THE INSERTER BROKE OFF AND REMAINED INSIDE THE BONE. THE CASE WAS COMPLETED WITH THE PRODUCT IN PLACE. THERE WAS NO SIGNIFICANT PROCEDURAL DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026.
Patient problems: Foreign Body In Patient
MAUDE report 24257218 ↗MalfunctionFeb 4, 2026Device Dislodged or Dislocated
ON (B)(6) 2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK ANCHOR PULLED OUT WHILE TENSION WAS BEING APPLIED TO THE LOOP AFTER THE ANCHOR WAS PLACED INTO BONE. THE ANCHOR WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-3740SP ANCHOR. THERE WAS NO SIGNIFICANT PROCEDURAL DELAY, NO ADDITIONAL ANESTHESIA WAS REQUIRED, AND NO ADVERSE EFFECTS WERE REPORTED. THE ISSUE OCCURRED DURING A PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257190 ↗MalfunctionJan 13, 2026Break
ON 23-DEC-2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT THE ANCHOR SHAFT TIP BROKE ON AN AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK ANCHOR AFTER INSERTION INTO THE PILOT HOLE. THE BROKEN FRAGMENT COULD NOT BE RETRIEVED. THE ANCHOR REMAINED FUNCTIONAL AND WAS USED TO COMPLETE THE PROCEDURE WITHOUT ADDITIONAL ISSUES. NO SIGNIFICANT SURGICAL DELAY OCCURRED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE EVENT WAS IDENTIFIED DURING THE PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 05-JAN-2026: THIS ISSUE OCCURRED DURING A LATERAL EXTRA-ARTICULAR TENODESIS.
Patient problems: Foreign Body In Patient
MAUDE report 24051826 ↗
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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.