Arthrex® AR-3602-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00888867206953), received between Jul 7, 2017 and Sep 1, 2026 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Device Dislodged or Dislocated

  On (b)(6) 2026, it was reported by a sales Representative via (b)(6) that an AR-3602-2 fibertak double loaded suture tape anchor pulled out during a rotator cuff repair. Noticed during a case, anchor removed, and case completed with no device with no patient effect.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546930 ↗
• MalfunctionFeb 20, 2026Break

  ON 4TH FEB 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-3602-2, FIBERTAK¿ SUTURE ANCHOR, DOUBLE LOADED WITH 1.3 MM SUTURETAPE¿ (WHITE AND WHITE/BLUE), THE ANCHOR SHAFT BROKE WHEN THE ANCHOR WAS TAPPED WITH A FIST TO FACILITATE INSERTION. THIS WAS DETECTED DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING AR-1934BFT-2. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399689 ↗
• MalfunctionOct 30, 2025Break; Break

  ON (B)(6) 2025 MAJUNG - FURTHER INFORMATION WAS RECEIVED FROM ARTHREX UK: THE ANCHOR WAS SOLID, BUT THE TIP OF THE INTRODUCED DRIVER BROKE. HE SAID, IT WAS FLUSH, SO HE LEFT IT IN THE PATIENT. THE SURGEON ISN¿T CONCERNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23429714 ↗
• MalfunctionJun 24, 2025Positioning Failure; Positioning Failure

  ON 06/03/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT (2) AR-3602-2 FIBERTAK¿ SUTURE ANCHORS AFTER IMPLANTING THE ANCHOR, THE TWO 1.3MM FIBERTAK ANCHORS LOOSENED WHEN KNOTTING THE FABRIC. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2025, WHEN THE ARTHREX SUBSIDIARY EMPLOYEE STATED THIS OCCURRED DURING AN ARTHROSCOPY PROCEDURE TO REPAIR THE RIGHT SHOULDER LABRAL TEAR. THE PATIENT HAD GOOD BONE QUALITY. A 1.7MM FIBERTAK ANCHOR DRILL WAS USED TO PREPARE THE BONE SOCKET FOR THE IMPLANT'S INSERTION. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. ANOTHER FIBERTAK ANCHOR WAS USED TO COMPLETE THE CASE. THIS INCREASED THE SURGICAL TIME BY ANOTHER TWO HOURS. THERE WAS NO NEED TO ADMINISTER ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 22317786 ↗
• MalfunctionJun 23, 2025Positioning Failure; Positioning Failure

  ON 06/03/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT (2) AR-3602-2 FIBERTAK¿ SUTURE ANCHORS AFTER IMPLANTING THE ANCHOR, THE TWO 1.3MM FIBERTAK ANCHORS LOOSENED WHEN KNOTTING THE FABRIC. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 06/17/2025, WHEN THE ARTHREX SUBSIDIARY EMPLOYEE STATED THIS OCCURRED DURING AN ARTHROSCOPY PROCEDURE TO REPAIR THE RIGHT SHOULDER LABRAL TEAR. THE PATIENT HAD GOOD BONE QUALITY. A 1.7MM FIBERTAK ANCHOR DRILL WAS USED TO PREPARE THE BONE SOCKET FOR THE IMPLANT'S INSERTION. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. ANOTHER FIBERTAK ANCHOR WAS USED TO COMPLETE THE CASE. THIS INCREASED THE SURGICAL TIME BY ANOTHER TWO HOURS. THERE WAS NO NEED TO ADMINISTER ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 22310093 ↗
• MalfunctionFeb 6, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-3602-2 FIBERTAK¿ SUTURE ANCHOR BROKE. THIS OCCURRED DURING USE THE ANCHOR USED BROKE THE TAPE DURING THE PASSAGE AND THE OTHER ANCHOR DIDN'T PULL, IT CAME LOOSE COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321223 ↗
• MalfunctionSep 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE GUIDEWIRE BROKE DURING IMPLANT INSERTION. 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 20191400 ↗
• MalfunctionSep 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE GUIDEWIRE BROKE DURING IMPLANT INSERTION. 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 20191253 ↗
• MalfunctionJun 21, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ON 05/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3602-2 DOUBLE LOADED FIBERTAK INSERTER TIP BENT UPON IMPLANTATION. THE ANCHOR PULLED OUT AND THE SHEATH WAS BUT DUE TO THE TIP OF THE INSERTER BENDING. THIS WAS NOTICED ONCE THE INSERTER WAS REMOVED FROM INSIDE THE PATIENT. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING ANOTHER AR-3602-2 DOUBLE LOADED FIBERTAK.

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

  MAUDE report 19585868 ↗
• MalfunctionJun 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 1/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3602-2 FIBERTAK SUTURE ANCHOR PULLED OUT OF IMPLANTATION SITE AND GOT STUCK IN THE DRILL GUIDE AS IT WAS BEING REMOVED. SURGEON WAS UNABLE TO RELOAD THE ANCHOR SO A NEW AR-3602-2 FIBERTAK SUTURE ANCHOR, FROM THE SAME LOT NUMBER, WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A SLAP REPAIR PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495226 ↗
• MalfunctionJun 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/3/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-3602-2 FIBERTAK PULLED OUT DURING INSERTION. THIS WAS DISCOVERED DURING USE IN A MENISCAL REPAIR ON 11/3/2021. THE CASE WAS COMPLETED BY USING A NEW AR-3602-2.

  Patient problems: Insufficient Information

  MAUDE report 19453262 ↗
• MalfunctionApr 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS (B)(4) THAT AN AR-3602-2 FIBERTAK SUTURE TAPE ANCHOR CAME LOOSE AFTER IT WAS INSERTED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183683 ↗
• MalfunctionDec 21, 2023Break; Break

  ON 11/22/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AR-3602-2 FIBERTAK PULLED OUT OR BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18378846 ↗
• MalfunctionSep 5, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SUBSIDIARY REPRESENTATIVE VIA SEMS THAT AN AR-3602-2 ANCHOR BROKE DURING PLACEMENT. THE PROCEDURE WAS COMPLETED WITH THE ANCHOR.

  Patient problems: Insufficient Information

  MAUDE report 17683490 ↗
• MalfunctionJul 24, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-3602-2 FIBERTAK SHAFT BROKE WHILE BEING INSERTED THROUGH THE CURVED GUIDE. ALL THE BROKEN FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED USING A NEW PRODUCT. THIS WAS DISCOVERED DURING A MENISCUS REPAIR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THE SHAFT BROKEN FRAGMENTS WERE CONTAINED WITHIN THE CURVED GUIDE AND WERE NOT LOOSE IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377512 ↗
• MalfunctionMar 8, 2023Break; Break

  ON 2/20/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-3602-2 FIBERTAK SUTURE ANCHOR INSERTER TIP BROKE OFF IN THE PATIENT'S BONE. IT WAS CONFIRMED THROUGH RADIOGRAPHY THAT THE BROKEN TIP WAS IN THE PATIENT ALONG WITH THE ANCHOR; FRAGMENTS WERE NOT RETRIEVED. THIS WAS DISCOVERED DURING AN A/S BANKART REPAIR PROCEDURE ON (B)(6) 2022. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 16501095 ↗
• MalfunctionDec 27, 2022Break

  ON 9/26/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3602-2 FIBERTAK SUTURE ANCHOR BROKE UPON INSERTION. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 9/26/2022: THIS WAS DISCOVERED DURING AN OPEN SUBSCAP PROCEDURE. THE SHAFT OF THE INSERTER BROKE OFF FROM THE RED HANDLE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT AND CASE WAS COMPLETED USING ANOTHER AR-3602-2 FIBERTAK SUTURE ANCHOR. NO FURTHER ISSUES HAS BEEN REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16052008 ↗
• MalfunctionDec 27, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE DEVICE BROKE AT THE STICK INSIDE THE PATIENT. 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 14-DEC-2022. FURTHER INFORMATION REVEALED THAT THE NEEDLE/SHAFT OF THE DEVICE BROKE THE TIP. THE SURGEON COULD RETRIEVE THE BROKEN PIECES DURING THE SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051792 ↗
• MalfunctionDec 7, 2022Break; Output Problem

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE TIP OF THE DEVICE BROKE OFF AND REMAINED IN THE BONE OF THE PATIENT. THE SURGERY TIME HAS NOT INCREASED DUE TO THE ERROR. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15931161 ↗
• MalfunctionApr 18, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-3602-2 FIBERTAK INSERTER BROKE WHEN THE ANCHOR WAS BEING INSERTER INTO THE PATIENT. BROKEN PIECES WERE NOT RETRIEVED AND EVERYTHING REMAINS IN THE PATIENT, AS CASE WAS COMPLETED USING THE DEVICE. THIS OCCURRED DURING A RCR PROCEDURE (B)(6) 2022. HOWEVER; DURING THE PROCEDURE, SURGEON WAS UNAWARE THE INSERTER BROKE IN THE PATIENT. NO FURTHER INFORMATION HAS BEEN GIVEN AT THIS TIME. ARTHREX EMPLOYEE CANNOT VERIFY WHETHER THE FIBERTAK WAS FROM LOT NUMBER 10149849 OR 10401372.

  Patient problems: Foreign Body In Patient

  MAUDE report 14136489 ↗
• MalfunctionApr 1, 2021Break

  IT WAS REPORTED THAT THE TIP OF THE AR-3602-2 ANCHOR BROKE OFF IN THE BONE AFTER INSERTION. THE CASE WAS COMPLETED BY USING ANOTHER ANCHOR.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602353 ↗
• InjuryMar 9, 2020Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A POSTERIOR LABRUM REFIXATION, THE TIP OF THE DEVICE BROKE OFF WHICH CAUSES THAT THE SUTURE COULD NOT MOVE FREELY ANYMORE. THE FRAGMENT COULD NOT BE RETRIEVED. THE TWO SUTURES HAD TO BE CUT OFF AND KNOTTED TOGETHER. ONE SUTURE WAS WELL FIXED TO STAY IN PLACE UPON TENSION. THE SURGERY WAS SUCCESSFULLY FINISHED BY RETHREADING THE LABRUM WITH A FW 2 AND KNOTTING TO THE FIXED SUTURE FROM THE ANCHOR. UPDATE 20-FEB-2020: BONE QUALITY WAS GOOD, BONE PREP. AS USUAL, DRILLING THROUGH A CANNULA, DELAY OF SURGERY ABOUT 30 MIN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9806219 ↗
• InjuryJul 13, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROXIMAL BICEPS TENODESIS REPAIR PROCEDURE ON (B)(6) 2018. DURING THIS PROCEDURE, A FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE, AR-3602-2, WAS IMPLANTED. SOON AFTER THE PROCEDURE, THE PATIENT BEGAN TO EXPERIENCE PAIN AT THE INCISION SITE. ON (B)(6) 2018, THE PATIENT WAS SEEN AT HIS SURGEON¿S OFFICE FOR A WASHOUT OF THE WOUND. THE SURGEON STATED THAT THE WOUND BEGAN TO ¿WEEP¿. THE SURGEON HAS STATED THAT HE WILL REMOVE THE IMPLANTS, HOWEVER, A DATE OF SURGERY FOR THE REVISION HAS NOT BEEN SCHEDULED AS OF YET. PENDING ADDITIONAL INFORMATION. ADDITIONAL INFORMATION PROVIDED ON 6/26/2018: THE SURGEON EXPLANTED THE AR-3602-2 ON (B)(6) DURING THE PATIENT'S VISIT AND DISCARDED. HE DID NOT REPLACE IT WITH ANYTHING ELSE, HE LEFT IT AS IS.

  Patient problems: Discharge; Pain

  MAUDE report 7685062 ↗
• InjuryJul 7, 2017Component Missing

  IT WAS REPORTED THAT THREE FIBERTAK DOUBLE LOADED W/ 1.3 SUTURE TAPE WERE USED IN A BONY BANKHART REPAIR CASE. UPON COMPLETING OF THE CASE, A C-ARM WAS BROUGHT IN TO CHECK THE REDUCTION UNDER FLUOROSCOPY AND FOUND A METAL FRAGMENT EMBEDDED IN THE GLENOID. AFTER CHECKING ALL INSTRUMENTS, THE END OF ONE OF THE FIBERTAK DRIVERS WAS FOUND TO BE MISSING THE TIP. ADDITIONAL INFORMATION RECEIVED 7/3/2017: THE SURGEON DOES NOT PLAN ON A SECOND SURGERY TO REMOVE THE UN-RETRIEVED FRAGMENT. THE DEVICES WERE DISPOSED OF AFTER THE CASE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6692667 ↗