Arthrex® AR-3600-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888867206960), received between Apr 5, 2018 and Dec 24, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-3600-2 FIBERTAK CAME LOOSE. IT WAS REPORTED THAT AFTER INSERTING THE SECOND FIBERTAK ANCHOR, A SUTURE WAS PASSED USING THE SUTURELASSO, AND WHEN PULLING THE NITINOL WITH SOME FORCE, THE FIRST FIBERTAK ANCHOR WAS PULLED OUT. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. THE PROCEDURE WAS COMPLETED USING A PUSHLOCK AND A FIBERLINK TO REINSERT THE FIRST PORTION OF THE SATURATED LABRUM. THE PATIENT¿S BONE QUALITY WAS REPORTED AS GOOD. ADDITIONAL INFORMATION PROVIDED 17-DEC-2025: IT WAS FURTHER REPORTED THIS OCCURRED DURING A SHOULDER ARTHROSCOPY PROCEDURE WITH NO CASE DELAY OR ADDITIONAL ANESTHESIA ADMINISTERED. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887523 ↗
• MalfunctionSep 5, 2025Break; Break

  ON 18TH AUGUST 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR 2 UNITS OF AR-3600-2, FIBERTAK¿ SUTURE ANCHOR WITH #2 FIBERWIRE® CL (DOUBLE LOADED), THE FIBERTAK TIP WAS BROKEN DURING ATFL REPAIR FIBULA SITE INSERTION. 2 ANCHORS TIP HAD THE SAME ISSUE. THIS WAS DETECTED DURING USE IN AN ATFL REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRD FIBERTAK. THE AR-3600ND-2 WAS USED TO DRILL THE HOLE REPEATEDLY. NO FRAGMENT WAS LEFT INSIDE THE PATIENT. THE BONE DENSITY TEST IS NOT A STANDARD PROTOCOL FOR ATFL REPAIR CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978791 ↗
• MalfunctionSep 13, 2024Break; Break

  IT WAS REPORTED THAT DURING A LATERJET CAPSULAR SUTURING THE SUTURE BROKE WHEN KNOTTED. 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. UPDATE 04-SEP 2024: FURTHER INFORMATION WAS PROVIDED THAT THE BROKEN PIECE WAS RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20214907 ↗
• MalfunctionSep 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY SURGERY THE SUTURES OF THE DEVICE TORE OFF WHEN TYING KNOTS. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-8934BCF-2). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212675 ↗
• MalfunctionJun 24, 2024Break; Break

  ON 5/31/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3600-2 FIBERTAK SUTURE ANCHOR AND AN AR-3638DC KNOTLESS FIBERTAK DISPOABLE KIT, CURVED HAD AN ISSUE DURING A SHOULDER ROTATOR CUFF REPAIR PROCEDURE WITH BICEPS TENODESIS ON (B)(6) 2024. THE SURGEON PUT THE DRILL GUIDE ON, DRILLED AND INSERTED THE SUTURE ANCHOR THROUGH THE DRILL GUIDE, WHEN A PLASTIC PART OF THE ANCHOR INSERTER THAT WAS OUTSIDE OF THE PATIENT, BROKE OFF INSIDE THE DRILL GUIDE. THE INSERTER COULD NOT BE REMOVED FROM THE DRILL GUIDE, THEY HAD FUSED TOGETHER. WHEN REMOVING THE INSERTER TOGETHER WITH THE DRILL GUIDE FROM THE PATIENT, THE KNOTLESS SUTURE ANCHOR WAS PULLED OUT AS WELL. NOTHING BROKE OFF INSIDE THE PATIENT, THE BROKEN PLASTIC PIECE WAS CONTAINED WITHIN THE DRILL GUIDE AND EVERYTHING WAS REMOVED. THE SAME SPOT WAS USED, THE HOLE WAS MADE BIGGER AND AN AR-1927PSF-475 SUTURE ANCHOR, PEEK CORKSCREW FT WITH AN UNKNOWN LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO HARM TO THE PATIENT. THERE WAS NO CASE DELAY REPORTED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE COMPLAINT DEVICES WERE DISCARDED, BUT PICTURES WERE TAKEN. THIS OCCURRED DURING USE WITH NO REPORTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593754 ↗
• MalfunctionJun 18, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT, THE THREAD WAS LOOSE AT THE TIP OF THE AR-3600-2 ANCHOR. NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559434 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY REPAIR PROCEDURE, WHEN THE SURGEON WAS ENTERING THE FIBERTAK THROUGH THE INSTRUMENTS, IT ENTERS WITH DIFFICULTY, AS THE INPUT PROGRESSES, IT BECOMES DEFORMED AND CAUSES DETACHMENT OF THE SUTURE. THIS ISSUE OCCURRED WITH 3 IMPLANTS. THE CASE WAS COMPLETED BY USING A NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558761 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY REPAIR PROCEDURE, WHEN THE SURGEON WAS ENTERING THE FIBERTAK THROUGH THE INSTRUMENTS, IT ENTERS WITH DIFFICULTY, AS THE INPUT PROGRESSES, IT BECOMES DEFORMED AND CAUSES DETACHMENT OF THE SUTURE. THIS ISSUE OCCURRED WITH 3 IMPLANTS. THE CASE WAS COMPLETED BY USING A NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558720 ↗
• MalfunctionDec 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(3) 2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-3600-2 FIBERTAK¿ SUTURE ANCHORS DIDN'T STAY IN PLACE EVEN WITH THE CORRECT TECHNIQUE, IT WOULDN'T LOCK INTO THE BONE. THIS OCCURRED DURING A CASE, WITH NO EFFECT ON THE PATIENT, ANOTHER DEVICE WAS USED TO PROCEED WITH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18277880 ↗
• MalfunctionMay 3, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3600-2 FIBERTAK SUTURE ANCHOR FORKED LIKE TIP BROKE INSIDE THE PATIENT. WHEN SURGEON ATTEMPTED TO MALLET IN THE ANCHOR, THE DRILL GUIDE SHIFTED AND THE TIP OF THE FIBERTAK INSERTER BROKE. THE FRAGMENT WERE NOT RETRIEVED AND REMAIN IN THE PATIENTS CORTICAL BONE. SURGEON CREATED A NEW BONE SOCKET AND USED ANOTHER ANCHOR TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A BICEP TENODESIS PROCEDURE ON (B)(6) 2022. NO FURTHER ISSUES HAS BEEN REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14269611 ↗
• MalfunctionMar 7, 2022Break; Entrapment of Device

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3600-2 DOUBLE LOADED FIBERTAK WAS INSERTED INTO THE BONE SOCKET AND THE INSERTER SHAFT WAS REMOVED. IT WAS THEN, ON THE BACK TABLE, NOTICED THAT ONE OF THE TWO FORKS ON THE TIP BROKE OFF. AN X-RAY WAS TAKEN AND THE FRAGMENT OFF THE TIP OF THE INSERTED COULD BE SEEN IN THE PERIOSTEUM AND WAS NOT ABLE TO BE REMOVED. CASE WAS COMPLETED WITH ANOTHER ANCHOR. THIS WAS DISCOVERED DURING AN OPEN BICEPS TENODESIS PROCEDURE. NO FURTHERS ISSUES REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13684777 ↗
• MalfunctionNov 8, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-3600-2 FIBERTAK SUTURE ANCHOR TIP BROKE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770613 ↗
• MalfunctionJul 27, 2021Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY REPAIR, UPON INSERTION OF THE AR-3600-2, THE METAL TIP BROKE APPROXIMATELY HALF A CENTIMETER. THE SURGEON ATTEMPTED TO REMOVAL THE FRAGMENT BUT WAS UNSUCCESSFUL. THE CASE WAS COMPLETED BY USING A NEW AR-3600-2.

  Patient problems: Foreign Body In Patient

  MAUDE report 12231834 ↗
• InjuryApr 5, 2018Break; Detachment Of Device Component; Difficult to Insert

  IT WAS REPORTED THAT THE DRIVER TIP BROKE-OFF IN THE PATIENT. PATIENT WAS ON THE TABLE AT THE TIME OF CALL. FOLLOW-UP INVESTIGATION: THE SURGEON WAS INSERTING AN AR-3600-2 WITH THE INSERTER INSTRUMENT THAT COMES WITH THE ANCHOR. THE ANCHOR WAS FULLY INSERTED BUT IN THE PROCESS OF INSERTING THE ANCHOR, ONE OF THE PRONGS ON THE VERY DISTAL NITINOL TIP OF THE INSERTER BROKE-OFF IN THE PATIENT BONE. THE SURGEON CHOSE TO LEAVE THE PIECE IN THE BONE RATHER THAN DAMAGE BONE ATTEMPTING TO REMOVE THE PIECE. THE SCREW WAS LEFT IN PLACE AND USED TO COMPLETE THE PROCEDURE. THE INSERTER INSTRUMENT WAS DISCARDED AT THE TIME OF PROCEDURE AND IS NOT AVAILABLE TO RETURN FOR EVALUATION. THE PROCEDURE WAS A TRICEPS REPAIR.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7398757 ↗