Arthrex® AR-3681Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867305458), received between Jul 28, 2023 and Sep 18, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828808 ↗
• MalfunctionFeb 18, 2026Break

  ON 30-JAN-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT DURING A SURGICAL PROCEDURE INVOLVING AN AR-3681 FIBERTAK BUTTON, THE SURGEON EXPERIENCED DIFFICULTY DURING INSERTION. AFTER PLACING THE GUIDE AND DRILLING THE HOLE, THE ANCHOR REQUIRED AN UNUSUAL FORCE TO ADVANCE DOWN THE INSERTER. A SIGNIFICANT AMOUNT OF FORCE WAS THEN NEEDED TO MALLET THE ANCHOR INTO THE PRE-DRILLED HOLE. WHEN THE SURGEON ATTEMPTED TO CONVERT THE #2 FIBERWIRE WITH THE SHUTTLING LINKS, THE SHUTTLING SUTURES WOULD NOT ADVANCE. THE SURGEON REPORTED THAT THE SUTURE ULTIMATELY BROKE WHILE ATTEMPTING TO CONVERT IT. THE SAME DRILL AND GUIDE WERE SUBSEQUENTLY USED FOR A SECOND ANCHOR, AND THE SECOND ANCHOR WAS INSERTED WITHOUT ISSUE. THIS WAS DISCOVERED DURING A PEC REPAIR PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 09-FEB-2026: ALL FRAGMENTS WERE RETRIEVED. THE CASE PROCEEDED WITHOUT DELAY, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. BONE QUALITY WAS ASSESSED AS GOOD, WITH HARD BONE NOTED.

  Patient problems: Insufficient Information

  MAUDE report 24379210 ↗
• MalfunctionJan 12, 2026Detachment of Device or Device Component

  ON 22-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3681 FIBERTAK BUTTON BENT UPON INSERTION INTO THE DRILL HOLE, CAUSING THE IMPLANT TO DETACH FROM THE INSERTER AND RENDERING THE INSERTER UNUSABLE (SEE ATTACHED PHOTO). THE CASE WAS COMPLETED BY OPENING A NEW ANCHOR, PREPARING AND DRILLING A NEW SITE, AND FINISHING THE PROCEDURE WITHOUT COMPLICATIONS. THIS OCCURRED DURING A PROXIMAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED ON 24-DEC-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036320 ↗
• MalfunctionSep 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 08/27/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-3681 FIBERTAK BUTTONS MALFUNCTIONED DURING USE. WITH THE FIRST AR-3681 FIBERTAK BUTTON, THE LIMB FROM THE #2 FIBERLOOP FAILED TO SHUTTLE THROUGH THE BUTTON SUCCESSFULLY AND SNAPPED AFTER BECOMING STUCK. WITH THE SECOND AR-3681 FIBERTAK BUTTON, THE ANCHOR INITIALLY SET PROPERLY, BUT WHEN THE SURGEON ATTEMPTED TO SHUTTLE THE SUTURE, THE IMPLANT POPPED OUT. IT WAS NOTED THAT APPROPRIATE COUNTER TENSION WAS MAINTAINED ON THE OTHER SHUTTLE SUTURES. THE CASE WAS COMPLETED, AND NO FURTHER DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING A SUBPECTORAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 09/03/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084209 ↗
• MalfunctionSep 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 08/27/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-3681 FIBERTAK BUTTONS MALFUNCTIONED DURING USE. WITH THE FIRST AR-3681 FIBERTAK BUTTON, THE LIMB FROM THE #2 FIBERLOOP FAILED TO SHUTTLE THROUGH THE BUTTON SUCCESSFULLY AND SNAPPED AFTER BECOMING STUCK. WITH THE SECOND AR-3681 FIBERTAK BUTTON, THE ANCHOR INITIALLY SET PROPERLY, BUT WHEN THE SURGEON ATTEMPTED TO SHUTTLE THE SUTURE, THE IMPLANT POPPED OUT. IT WAS NOTED THAT APPROPRIATE COUNTER TENSION WAS MAINTAINED ON THE OTHER SHUTTLE SUTURES. THE CASE WAS COMPLETED, AND NO FURTHER DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING A SUBPECTORAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 09/03/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084205 ↗
• MalfunctionJul 3, 2025Defective Device; Defective Device

  ON (B)(6) 2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-3681 FIBERTAK BUTTON MALFUNCTIONED DURING USE. THE SURGEON PLACED THREE ANCHORS, AND UPON SETTING THE THIRD ANCHOR, THE ANCHOR WOULD NOT BUNCH/SET. THE ANCHOR PULLED FROM THE BONE, THEY ATTEMPTED TO RESET IT ON THE INSERTER AND TRY AGAIN, BUT THE SAME THING HAPPENED. AFTER INSPECTING THE BACK TABLE, THE ANCHOR WOULD NOT BUNCH WHEN ALL SUTURE LIMBS WERE PULLED. THEY OPTED TO OPEN A NEW ANCHOR, AND IT WORKED WITHOUT ISSUES TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PEC REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 06/23/2025: THE CASE WAS DELAYED 15 MINUTES. IT IS UNCERTAIN IF ADDED ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED ON OR AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22397068 ↗
• MalfunctionSep 17, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A BICEPS SURGERY THE ANCHOR COULD NOT BE PULLED IN AND WAS KNOTTED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20235891 ↗
• MalfunctionSep 17, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A BICEPS SURGERY THE ANCHOR COULD NOT BE PULLED IN AND WAS KNOTTED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20235670 ↗
• MalfunctionMay 9, 2024Unintended Movement; Unintended Movement

  ON 9/29/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN WHILE USING AN AR-3680 FIBERTAK BUTTON KIT, THE IMPLANT PULLED OUT. SURGEON OPENED AN AR-3681 FIBERTAK BUTTON ALONG WITH AN AR-7535 FIBERLINK SUTURE TAPE WHICH ALSO PULLED OUT. FINALLY CASE WAS COMPLETED WITH A PRODUCT FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 10/4/2022: THIS WAS DISCOVERED DURING AN RCR PROCEDURE AND NOTHING BROKE INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281052 ↗
• MalfunctionMay 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AR-3680 FIBERTAK PULLED OUT OF IMPLANTATION SITE. A NEW TUNNEL WAS OPENED AND AN AR-3681 FIBERTAK WAS OPENED, THIS ONE TOO, PULLED OUT OF IMPLANTATION SITE. CASE WAS COMPLETED BY USING A 7X10 TENODESIS SCREW. THIS WAS DISCOVERED DURING A BICEP TENODESIS PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 19277385 ↗
• MalfunctionApr 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6)2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA THE PHONE THAT AN AR-3680 (LINE #1) FIBERTAK BUTTON PULLED OUT OF THE BONE WHEN THE SURGEON CONVERTED THE REPAIR STITCH AFTER INSERTION, ALL THE AR-3680 WAS REMOVED. THE SURGEON OPENED AN AR-3681 (LINE #2) USING THE SAME INSERTION SITE AND THE SAME ISSUE OCCURRED, ALL THE AR-3681 WAS REMOVED FROM THE PATIENT. THIS WAS DISCOVERED DURING USE IN A BICEP TENODESIS PROCEDURE ON (B)(6)2021. THE CASE WAS COMPLETED BY OPENING A NEW AR-3680.

  Patient problems: Insufficient Information

  MAUDE report 19194154 ↗
• MalfunctionApr 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED ON 11/08/2022 BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-3681 FIBERTAK BUTTON SUTURE DID NOT PASS AND IMPLANT PULLED OUT. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172339 ↗
• MalfunctionJan 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3680 FIBERTAK BUTTON IMPLANT SYSTEM AND AN AR-3681 FIBERTAK BUTTON PULLED OUT DURING THE CONVERSION. THE CASE WAS COMPLETED USING THE FIBERLOOP AND FEEDING IT INTO A BUTTON. THIS WAS DISCOVERED DURING A PROXIMAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18552444 ↗
• MalfunctionAug 31, 2023Break; Break

  IT WAS REPORTED THAT BEFORE THE SURGERY, AN ISSUE OCCURRED WITH THE DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. UPDATE (B)(6) 09-AUG-2023: IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT DURING THE SURGERY AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662349 ↗
• MalfunctionJul 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6)2023, IT WAS REPORTED BY A SALE REPRESENTATIVE VIA EMAIL THAT AN AR-3680 FIBERTAK IMPLANT SYSTEM AND AN AR-3681 FIBERTAK BUTTON ANCHORS PULLED OUT OF THE IMPLANTATION SITE. WHEN SHUTTLING THE MECHANISM THROUGH THE KNOT, ONE STRAND GOES THROUGH, BUT THE OTHER STAND PULLS THE ANCHOR OUT. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 7/5/2023: THIS WAS DISCOVERED DURING A SUBPECTORAL BICEPS TENODESIS PROCEDURE ON (B)(6)2023. THE CASE WAS COMPLETED BY REMOVING BOTH FIBERTAK ANCHORS AND USING AN AR-2260 DISTAL BICEPS REPAIR IMPLANT SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 17417672 ↗