Arthrex® AR-3641Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00888867287457), received between Sep 28, 2021 and May 27, 2026 — classified as 2 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A BICEPS TENODESIS SURGERY THE ANCHOR PULLED OUT. PER COMPLAINT REPORTER 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 25299419 ↗
• MalfunctionMar 19, 2026Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED ON 17-MAR-2026: THIS ISSUE OCCURRED IN THE PATIENT DURING A ROTATOR CUFF REPAIR PROCEDURE. THE SUTURE BROKE ON ONE OF THE ANCHORS AT THE REPAIR SUTURE, AND ON THE OTHER ANCHORS, THE SHUTTLE SUTURE TORE. ALL BROKEN SUTURE FRAGMENTS WERE RETRIEVED, AND THE AFFECTED ANCHOR WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE, AN AR-3652TSP FIBERTAK RC SUTURE ANCHOR. THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642120 ↗
• MalfunctionMar 19, 2026Material Split, Cut or Torn

  ON 11-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT FOUR AR-3641 2.6 MM KNOTLESS FIBERTAK ANCHORS HAD ISSUES, WITH ONE OF THE SUTURES RIPPED, AFFECTING EITHER THE SHUTTLE LINK OR THE BLUE REPAIR SUTURE. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642050 ↗
• MalfunctionMar 19, 2026Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED ON 17-MAR-2026: THIS ISSUE OCCURRED IN THE PATIENT DURING A ROTATOR CUFF REPAIR PROCEDURE. THE SUTURE BROKE ON ONE OF THE ANCHORS AT THE REPAIR SUTURE, AND ON THE OTHER ANCHORS, THE SHUTTLE SUTURE TORE. ALL BROKEN SUTURE FRAGMENTS WERE RETRIEVED, AND THE AFFECTED ANCHOR WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE, AN AR-3652TSP FIBERTAK RC SUTURE ANCHOR. THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642034 ↗
• MalfunctionMar 19, 2026Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED ON 17-MAR-2026: THIS ISSUE OCCURRED IN THE PATIENT DURING A ROTATOR CUFF REPAIR PROCEDURE. THE SUTURE BROKE ON ONE OF THE ANCHORS AT THE REPAIR SUTURE, AND ON THE OTHER ANCHORS, THE SHUTTLE SUTURE TORE. ALL BROKEN SUTURE FRAGMENTS WERE RETRIEVED, AND THE AFFECTED ANCHOR WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE, AN AR-3652TSP FIBERTAK RC SUTURE ANCHOR. THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641673 ↗
• InjuryFeb 18, 2026Break

  IT WAS REPORTED THAT DURING A LATERAL EXTRA-ARTICULAR TENODESIS SURGERY IN THE KNEE THE INSERTER BROKE 5 CM FROM THE TIP HAVING BENT. THE FORKED TIP OF THE ANCHOR REMAINED IN THE PATIENT. A SECOND SURGERY WAS PLANNED FOR (B)(6) 2026 TO REMOVE THE BROKEN PART. PER COMPLAINT REPORTER THERE WAS NO FURTHER 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. UPDATE 10-FEB-2026: FURTHER INFORMATION WAS PROVIDED THAT CONFIRMED THAT THE SECOND SURGERY WAS DONE AT (B)(6) 2026 IN THE EVENING TO REMOVE THE BROKEN PART.

  Patient problems: Failure of Implant

  MAUDE report 24380369 ↗
• MalfunctionJul 16, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A SURGERY WHEN THE SURGEON TRIED TI IMPLANT THE FIBERTAK IT FAILED TO BE DEPLOYED. PER COMPLAINT REPORTER 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 22523798 ↗
• MalfunctionFeb 26, 2025Break; Failure to Advance; Break; Failure to Advance

  ON 02/12/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3641 2.6 MM KNOTLESS FIBERTAK ANCHOR WOULD NOT ADVANCE WHILE INSERTING THE ANCHOR AFTER CORRECTLY DRILLING FOR THE ANCHOR WITH MULTIPLE CYCLES. THEY DECIDED TO STOP AND SEE WHERE THEY WERE AND NOTICED THAT ONE OF THE PRONGS OF THE INSERTER HAD BROKEN OFF. THEY RETRIEVED THE BROKEN TIP AND COMPLETED THE CASE WITH ANOTHER AR-3641 2.6 MM KNOTLESS FIBERTAK ANCHOR (FROM A DIFFERENT LOT: 15109786), FOLLOWING THE SAME STEPS PREVIOUSLY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 02/18/2025: THE CASE WAS DELAYED DUE TO THE OPENING OF A NEW ANCHOR. ONE TO TWO MINUTES OF ADDED ANESTHESIA WAS ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED. THIS WAS DISCOVERED DURING A LATERAL EPICONDYLE REPAIR ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21467343 ↗
• MalfunctionFeb 25, 2025Break; Break

  ON 02/13/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-3641 2.6 MM KNOTLESS FIBERTAK ANCHOR HAD THE TAPE SIDE OF THE SHUTTLE SUTURE BROKEN OFF WHEN TRYING TO RETRIEVE THE TAPE TO CONVERT THE ANCHOR DUE TO THE SHUTTLE ANCHOR BEING STUCK AND WOULD NOT SLIDE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 02/19/2025: THE FRAYED SUTURE WAS RETRIEVED FROM THE PATIENT. ENOUGH TENSION WAS ACCOMPLISHED WITH ONE KNOTLESS ANCHOR, SO THEY DECIDED TO FOREGO THE SECOND THAT HAD BROKEN. THERE WAS NO CASE DELAY; THEREFORE, NO ADDITIONAL ANESTHESIA WAS REQUIRED. THIS WAS DISCOVERED DURING A REMPLISSAGE OF THE HILLS SACH LESION ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459266 ↗
• MalfunctionFeb 19, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE LOOP OF THE DEVICE DIDN'T TIGHTEN. PER COMPLAINT REPORTER 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 21409831 ↗
• MalfunctionNov 26, 2024Material Frayed; Material Frayed

  ON 11/4/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3641 2.6 MM KNOTLESS FIBERTAK SHUTTLE SUTURE WAS FRAYED IN THE MIDDLE; THIS WAS NOTICED AFTER IMPLANTING THE ANCHOR. THE REPAIR SUTURE COULD NOT BE FULLY SHUTTLED THROUGH THE ANCHOR. THE CASE WAS COMPLETED USING ANOTHER ANCHOR. THIS WAS DISCOVERED DURING A REMPLISSAGE PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 11/12/2024: THE ANCHOR WAS REMOVED, AND ANOTHER IMPLANT WAS USED TO COMPLETE THE CASE. THE CASE WAS DELAYED FIFTEEN MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780178 ↗
• MalfunctionNov 5, 2024Break; Break

  ON 10/22/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT THE TIP OF AN AR-3641 2.6 MM KNOTLESS FIBERTAK SHAFT BROKE DURING THE INSERTION OF THE ANCHOR. THE ANCHOR WAS HAMMERED INTO THE BONE, BUT IT GOT STUCK AND COULD NOT BE INSERTED. THE INSERTER SHAFT BENT, AND THE TIP HAD BROKEN. AN X-RAY CONFIRMED THAT THE BROKEN PIECE WAS EMBEDDED IN THE BONE AND COULD NOT BE RETRIEVED. THE CASE WAS COMPLETED USING ANOTHER ANCHOR. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 10/29/2024: THIS WAS DISCOVERED DURING AN ACLR AND LET PROCEDURE. THE CASE WAS DELAYED LESS THAN FIFTEEN MINUTES; ADDITIONAL ANESTHESIA WAS NOT NEEDED. THERE'S NO AVAILABLE INFORMATION ON HOW THE CASE WAS COMPLETED, WHAT PRODUCTS WERE USED, AND THE X-RAY THAT WAS TAKEN INTRAOPERATIVELY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20613126 ↗
• MalfunctionSep 19, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  UPDATE FROM 15-OCT-2024 (B)(6). INITIALLY IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE IMPLANT HAS SLIPPED OUT OF PREPARED CHANNEL. HOWEVER, DURING THE RECEIVING INSPECTION BY ARTHREX GMBH PRODUCT SURVEILLANCE IT WAS FOUND THAT THE TIP IS BROKEN OFF. UPDATE 15-OCT-2024 (B)(6): FURTHER INFORMATION WAS RECEIVED THAT THE TIP DID NOT REMAIN IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256308 ↗
• MalfunctionAug 26, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE SURGERY THE GUIDEWIRE BROKE WHILE INSERTING THE IMPLANT. THE DEVICE DID BREAK INSIDE THE PATIENT BUT ALL PARTS WERE RETRIEVED. 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 20064242 ↗
• MalfunctionJul 9, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A MENISCUS RE-FIX SURGERY THAT THE SUTURES OF A FIBERTAK ANCHOR COULD NOT BE TIGHTENED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 19702789 ↗
• MalfunctionJun 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC SURGERY THE SUTURE TORE WHILE TIGHTENING THE LOOP. 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 19639120 ↗
• MalfunctionJun 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC SURGERY THE SUTURE TORE WHILE TIGHTENING THE LOOP. 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 19638824 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGERY A VERY SMALL PART OF THE TIP OF THE DEVICE BROKE OFF IN THE PATIENT. THE SURGEON WAS UNABLE TO REMOVE BROKEN PIECE FROM THE PATIENT AS THIS WOULD HAVE CAUSED FAR MORE DAMAGE THAN LEAVING THE FRAGMENT IN SITU ACCORDING TO THE CLINICAL DECISION BY THE OPERATION SENIOR CLINICIAN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19633409 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT DURING A LATERAL EXTRA-ARTICULAR TENODESIS SURGERY THE TIP OF THE DEVICE BROKE OFF AFTER INSERTION. THE SURGERY WAS FINISHED SUCCESSFULLY. AFTER THE SURGERY A X-RAY WAS TAKEN AND A PIECE OF METAL WAS NOTICED, BUT WAS UNCLEAR WHAT IT WAS. SIX WEEKS AFTER SURGERY ANOTHER X-RAY WAS TAKEN AND IT WAS NOTICED IT HAD TO BE THE TIP OF THE FIBERTAK. THE TIP WAS BROKEN AND STILL IN THE PATIENT. PATIENT IS AWARE OF IT AND NO FURTHER ACTION IS PLANNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19619655 ↗
• MalfunctionJun 12, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT WHEN THE KNOTLESS MECHANISM WAS PASSED DURING AN MCL RECONSTRUCTION, THE REPAIR SUTURE GOT STUCK AND WOULD NOT FULLY TENSION DOWN. THE SHUTTLE STITCH WAS FULLY REMOVED AND A LARGE LOOP WAS LEFT FROM THE REPAIR STITCH THAT WOULD NOT TENSION ANY FURTHER. THE CASE WAS COMPLETED BY USING AN ADDITIONAL 2.6 KNOTLESS FIBERTAK TO GET THE NECESSARY FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518010 ↗
• MalfunctionJun 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 08/17/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT WHILE USING AN AR-3641, FIBERTAK ANCHOR, THE REPAIR STITCH SUTURE WAS SNAGGED AND TORE. THE SURGEON THEN CUT OUT THE ANCHOR AND PUT IN A 4.75 SWIVELOCK TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19504760 ↗
• MalfunctionJun 7, 2024Failure to Advance; Failure to Advance

  ON 1/12/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (QTY. 3) OF AN AR-3641 2.6 MM KNOTLESS FIBERTAK HAD AN ISSUE. AFTER CONVERTING THE FIRST ANCHOR AND BRINGING THE TENDON OVER WITH NO ISSUE, IT WAS THEN NOTICED BY THE SURGEON, THAT THE SECOND ANCHOR BEGAN TO TENSION, AND THE REPAIR SUTURE STARTED TO LOOSEN. THE SURGEON MOVED ON TO THE THIRD ANCHOR AND THE SAME ISSUE OCCURRED AGAIN. AFTER ALL THREE ANCHORS WERE CONVERTED AND THE TENDON WAS BROUGHT BACK TO ITS CORRECT POSITION, ALL ANCHORS COULD BE SEEN LOOSENING. REPAIR SUTURES WERE PLACED INTO A SWIVELOCK AND TENSIONED DOWN TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN PROXIMAL HAMSTRING REPAIR ON (B)(6) 2023 WITH NO PATENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19485457 ↗
• MalfunctionJun 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 12/7/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3641 2.6 MM KNOTLESS FIBERTAK DID NOT SEAT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 12/8/2022. PER SALES REPRESENTATIVE, THE ACTUAL PART NUMBER IS AN AR-3671 FIBERTAK BICEPS IMPLANT. THIS WAS DISCOVERED DURING AN ELBOW MEDIAL EPICONDYLE PROCEDURE AND COMPLETED USING ANOTHER AR-3671 FIBERTAK BICEPS IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19453228 ↗
• MalfunctionMay 13, 2024Break; Break

  ON 02/13/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT (3) AR-3641 KNOTLESS FIBERTAK THE SHUTTLE SUTURE SNAPPED AT THE TAPE SIDE BEFORE PASSING THE REPAIR STITCH. PRIOR TO THE FAILURE, SURGEON HAD USED (5) AR-3636 KNOTLESS FIBERTAK TO REPAIR THE BANKART AND SLAP WITHOUT ISSUE. TO COMPLETE THE REMPLISSAGE PORTION OF THE PROCEDURE, SURGEON USED (2) (3) AR-3641 KNOTLESS FIBERTAK, FROM A DIFFERENT PART NUMBER AFTER THE THREE FAILED. THIS WAS DISCOVERED DURING AN BANKART, SLAP, AND REMPLISSAGE PROCEDURE ON (B)(6) 2023. CASE WAS COMPLETED SUCCESSFULLY AND THE BROKEN SUTURES WERE REMOVED FROM INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19296783 ↗
• MalfunctionMay 9, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED ON 08/23/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3641 FIBERTAK ANCHOR WOULD NOT CINCH DOWN, SUTURE WAS CUT OUT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280244 ↗