Arthrex® AR-3641SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00888867341906), received between Oct 31, 2022 and Sep 23, 2026 — classified as 7 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (23 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  On 08-Sep-2026, a sales representative reported via email that an AR-3641SP Self-Punching Knotless 2.6 FiberTak Anchor experienced an issue during a subscapularis repair procedure performed on (b)(6)-2026. The anchor was inserted through the guide, implanted, and set as intended. The shuttle sutures were reported to slide freely. After the repair suture was passed through the subscapularis tendon and shuttling was initiated, the shuttle suture snapped before the repair suture reached the anchor. The reporter stated that minimal force was being applied and no resistance had been encountered at the time the shuttle suture broke.The anchor was subsequently drilled out and replaced with another AR-3641SP Self-Punching Knotless 2.6 FiberTak Anchor (Lot 15459438). The procedure was completed successfully with the replacement device. No remnants of the initial anchor remained in the patient. The reported delay was approximately one minute, and no additional anesthesia was required. No patient harm was reported.Additional information was received on 10-Sep-2026:The shuttle suture broke approximately 3 inches short of the passing loop. The surgeon reported that the shuttle suture had been p

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867265 ↗
• MalfunctionSep 15, 2026Device Dislodged or Dislocated

  On 02-SEP-2026, it was reported by a sales representative via phone that an AR-3641SP Knotless FiberTak anchor's repair stitch was shuttled and it pulled out. Another AR-3641SP anchor was used to complete the case. This occurred during implantation with no patient impact. There was no case delay or additional surgery required.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776351 ↗
• MalfunctionSep 15, 2026Failure to Advance

  On 28-Aug-2026, a sales representative reported via email that an AR-3641SP Knotless 2.6 FiberTak Soft Anchor experienced a product issue during use. During a glute repair procedure on (b)(6) 2026, the repair stitch could not be shuttled through the knotless mechanism. The suture advanced approximately halfway before no longer progressing. Additional tension was applied in an attempt to complete the shuttling process, at which point the suture avulsed from the anchor. The anchor remained implanted in the patient. No harm to the patient was reported.Additional information was received on 31-Aug-2026:The shuttle stitch broke and released from the anchor. No visible damage to the anchor, suture, or knotless mechanism was observed prior to implantation.The anchor remained securely fixed in the bone after the suture avulsed. No unintended device fragments remained in the patient. All detached material was retrieved during the procedure. The anchor body was left in place.The repair was completed using another Arthrex implant, AR-3633SP, placed adjacent to the initial anchor placement site. The procedure was delayed approximately 30 seconds while the replacement anchor was inserted. Appro

  Patient problems: Foreign Body In Patient

  MAUDE report 50774576 ↗
• MalfunctionApr 2, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE ROTATOR CUFF SURGERY, THE SUTURE OF THE DEVICE TORE. 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 24769601 ↗
• MalfunctionApr 1, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE ROTATOR CUFF SURGERY, THE SUTURE OF THE DEVICE TORE. 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 24753493 ↗
• MalfunctionFeb 10, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A BICEPS TENODOSIS SURGERY THE SHUTTLE SUTURE TORE WHILE PULLING IN. 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 24304617 ↗
• MalfunctionFeb 6, 2026Device Dislodged or Dislocated

  ON (B)(6) 2025, IT WAS REPORTED BY A PATIENT¿S LEGAL REPRESENTATIVE VIA EMAIL THAT THE PATIENT UNDERWENT REPAIR OF THE LEFT GLUTEUS MEDIUS MUSCLE PROCEDURE. DURING THE PROCEDURE, ARTHREX 2.6 KNOTLESS FIBERTAK ANCHORS, PART AND LOT NUMBER UNKNOWN, WERE UTILIZED. FOLLOWING THE INITIAL SURGERY, THE PATIENT DEVELOPED A POST-SURGICAL INFECTION AND SUBSEQUENTLY UNDERWENT A WOUND REVISION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2023, DURING WHICH THE FIBERTAK ANCHORS WERE REMOVED. DESPITE THIS INTERVENTION, THE INFECTION PERSISTED. ON (B)(6) 2024, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO REMOVE SURGICAL HARDWARE FROM A PRIOR LEFT HIP REPLACEMENT PERFORMED IN 2020. THE HARDWARE REMOVAL WAS NECESSARY TO ADDRESS THE ONGOING INFECTION THAT THE PATIENT HAD BEEN SEEKING TREATMENT FOR SINCE THE INITIAL SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON 7-JAN-2026: THE PERIOPERATIVE REPORT CONFIRMS THAT THE SURGERY ON (B)(6) 2023 UTILIZED SEVEN AR-3641 2.6 MM KNOTLESS FIBERTAK ANCHORS. ONE OF THE SEVEN ANCHORS WAS INSERTED AND SUBSEQUENTLY PULLED OUT AND THEREFORE WAS NOT IMPLANTED. THE PROCEDURE WAS COMPLETED WITH SIX AR-3641 2.6 MM KNOTLESS FIBERTAK ANCHORS IMPLANTED. NO OTHER DEVICE MALFUNCTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279318 ↗
• InjuryFeb 6, 2026Patient Device Interaction Problem

  ON 11/19/2025, IT WAS REPORTED BY A PATIENT¿S LEGAL REPRESENTATIVE VIA EMAIL THAT THE PATIENT UNDERWENT REPAIR OF THE LEFT GLUTEUS MEDIUS MUSCLE PROCEDURE. DURING THE PROCEDURE, ARTHREX 2.6 KNOTLESS FIBERTAK ANCHORS, PART AND LOT NUMBER UNKNOWN, WERE UTILIZED. FOLLOWING THE INITIAL SURGERY, THE PATIENT DEVELOPED A POST-SURGICAL INFECTION AND SUBSEQUENTLY UNDERWENT A WOUND REVISION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2023, DURING WHICH THE FIBERTAK ANCHORS WERE REMOVED. DESPITE THIS INTERVENTION, THE INFECTION PERSISTED. ON (B)(6) 2024, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO REMOVE SURGICAL HARDWARE FROM A PRIOR LEFT HIP REPLACEMENT PERFORMED IN 2020. THE HARDWARE REMOVAL WAS NECESSARY TO ADDRESS THE ONGOING INFECTION THAT THE PATIENT HAD BEEN SEEKING TREATMENT FOR SINCE THE INITIAL SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON 7-JAN-2026: THE PERIOPERATIVE REPORT CONFIRMS THAT THE SURGERY ON (B)(6) 2023 UTILIZED SEVEN AR-3641 2.6 MM KNOTLESS FIBERTAK ANCHORS. ONE OF THE SEVEN ANCHORS WAS INSERTED AND SUBSEQUENTLY PULLED OUT AND THEREFORE WAS NOT IMPLANTED. THE PROCEDURE WAS COMPLETED WITH SIX AR-3641 2.6 MM KNOTLESS FIBERTAK ANCHORS IMPLANTED. NO OTHER DEVICE MALFUNCTIO

  Patient problems: Unspecified Infection

  MAUDE report 24279207 ↗
• InjuryFeb 6, 2026Patient Device Interaction Problem

  ON (B)(6) 2025, IT WAS REPORTED BY A PATIENT¿S LEGAL REPRESENTATIVE VIA EMAIL THAT THE PATIENT UNDERWENT REPAIR OF THE LEFT GLUTEUS MEDIUS MUSCLE PROCEDURE. DURING THE PROCEDURE, ARTHREX 2.6 KNOTLESS FIBERTAK ANCHORS, PART AND LOT NUMBER UNKNOWN, WERE UTILIZED. FOLLOWING THE INITIAL SURGERY, THE PATIENT DEVELOPED A POST-SURGICAL INFECTION AND SUBSEQUENTLY UNDERWENT A WOUND REVISION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2023, DURING WHICH THE FIBERTAK ANCHORS WERE REMOVED. DESPITE THIS INTERVENTION, THE INFECTION PERSISTED. ON (B)(6) 2024, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO REMOVE SURGICAL HARDWARE FROM A PRIOR LEFT HIP REPLACEMENT PERFORMED IN 2020. THE HARDWARE REMOVAL WAS NECESSARY TO ADDRESS THE ONGOING INFECTION THAT THE PATIENT HAD BEEN SEEKING TREATMENT FOR SINCE THE INITIAL SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON 7-JAN-2026: THE PERIOPERATIVE REPORT CONFIRMS THAT THE SURGERY ON (B)(6) 2023 UTILIZED SEVEN AR-3641 2.6 MM KNOTLESS FIBERTAK ANCHORS. ONE OF THE SEVEN ANCHORS WAS INSERTED AND SUBSEQUENTLY PULLED OUT AND THEREFORE WAS NOT IMPLANTED. THE PROCEDURE WAS COMPLETED WITH SIX AR-3641 2.6 MM KNOTLESS FIBERTAK ANCHORS IMPLANTED. NO OTHER DEVICE MALFUNCTI

  Patient problems: Unspecified Infection

  MAUDE report 24279064 ↗
• InjuryFeb 6, 2026Patient Device Interaction Problem

  ON 11/19/2025, IT WAS REPORTED BY A PATIENT¿S LEGAL REPRESENTATIVE VIA EMAIL THAT THE PATIENT UNDERWENT REPAIR OF THE LEFT GLUTEUS MEDIUS MUSCLE PROCEDURE. DURING THE PROCEDURE, ARTHREX 2.6 KNOTLESS FIBERTAK ANCHORS, PART AND LOT NUMBER UNKNOWN, WERE UTILIZED. FOLLOWING THE INITIAL SURGERY, THE PATIENT DEVELOPED A POST-SURGICAL INFECTION AND SUBSEQUENTLY UNDERWENT A WOUND REVISION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2023, DURING WHICH THE FIBERTAK ANCHORS WERE REMOVED. DESPITE THIS INTERVENTION, THE INFECTION PERSISTED. ON (B)(6) 2024, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO REMOVE SURGICAL HARDWARE FROM A PRIOR LEFT HIP REPLACEMENT PERFORMED IN 2020. THE HARDWARE REMOVAL WAS NECESSARY TO ADDRESS THE ONGOING INFECTION THAT THE PATIENT HAD BEEN SEEKING TREATMENT FOR SINCE THE INITIAL SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON 7-JAN-2026: THE PERIOPERATIVE REPORT CONFIRMS THAT THE SURGERY ON (B)(6) 2023 UTILIZED SEVEN AR-3641 2.6 MM KNOTLESS FIBERTAK ANCHORS. ONE OF THE SEVEN ANCHORS WAS INSERTED AND SUBSEQUENTLY PULLED OUT AND THEREFORE WAS NOT IMPLANTED. THE PROCEDURE WAS COMPLETED WITH SIX AR-3641 2.6 MM KNOTLESS FIBERTAK ANCHORS IMPLANTED. NO OTHER DEVICE MALFUNCTIO

  Patient problems: Unspecified Infection

  MAUDE report 24279057 ↗
• InjuryFeb 6, 2026Patient Device Interaction Problem

  ON (B)(6) 2025, IT WAS REPORTED BY A PATIENT¿S LEGAL REPRESENTATIVE VIA EMAIL THAT THE PATIENT UNDERWENT REPAIR OF THE LEFT GLUTEUS MEDIUS MUSCLE PROCEDURE. DURING THE PROCEDURE, ARTHREX 2.6 KNOTLESS FIBERTAK ANCHORS, PART AND LOT NUMBER UNKNOWN, WERE UTILIZED. FOLLOWING THE INITIAL SURGERY, THE PATIENT DEVELOPED A POST-SURGICAL INFECTION AND SUBSEQUENTLY UNDERWENT A WOUND REVISION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2023, DURING WHICH THE FIBERTAK ANCHORS WERE REMOVED. DESPITE THIS INTERVENTION, THE INFECTION PERSISTED. ON (B)(6) 2024, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO REMOVE SURGICAL HARDWARE FROM A PRIOR LEFT HIP REPLACEMENT PERFORMED IN 2020. THE HARDWARE REMOVAL WAS NECESSARY TO ADDRESS THE ONGOING INFECTION THAT THE PATIENT HAD BEEN SEEKING TREATMENT FOR SINCE THE INITIAL SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON 7-JAN-2026: THE PERIOPERATIVE REPORT CONFIRMS THAT THE SURGERY ON (B)(6) 2023 UTILIZED SEVEN AR-3641 2.6 MM KNOTLESS FIBERTAK ANCHORS. ONE OF THE SEVEN ANCHORS WAS INSERTED AND SUBSEQUENTLY PULLED OUT AND THEREFORE WAS NOT IMPLANTED. THE PROCEDURE WAS COMPLETED WITH SIX AR-3641 2.6 MM KNOTLESS FIBERTAK ANCHORS IMPLANTED. NO OTHER DEVICE MALFUNCTI

  Patient problems: Unspecified Infection

  MAUDE report 24278934 ↗
• InjuryFeb 6, 2026Patient Device Interaction Problem

  ON 11/19/2025, IT WAS REPORTED BY A PATIENT¿S LEGAL REPRESENTATIVE VIA EMAIL THAT THE PATIENT UNDERWENT REPAIR OF THE LEFT GLUTEUS MEDIUS MUSCLE PROCEDURE. DURING THE PROCEDURE, ARTHREX 2.6 KNOTLESS FIBERTAK ANCHORS, PART AND LOT NUMBER UNKNOWN, WERE UTILIZED. FOLLOWING THE INITIAL SURGERY, THE PATIENT DEVELOPED A POST-SURGICAL INFECTION AND SUBSEQUENTLY UNDERWENT A WOUND REVISION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2023, DURING WHICH THE FIBERTAK ANCHORS WERE REMOVED. DESPITE THIS INTERVENTION, THE INFECTION PERSISTED. ON (B)(6) 2024, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO REMOVE SURGICAL HARDWARE FROM A PRIOR LEFT HIP REPLACEMENT PERFORMED IN 2020. THE HARDWARE REMOVAL WAS NECESSARY TO ADDRESS THE ONGOING INFECTION THAT THE PATIENT HAD BEEN SEEKING TREATMENT FOR SINCE THE INITIAL SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON 7-JAN-2026: THE PERIOPERATIVE REPORT CONFIRMS THAT THE SURGERY ON (B)(6) 2023 UTILIZED SEVEN AR-3641 2.6 MM KNOTLESS FIBERTAK ANCHORS. ONE OF THE SEVEN ANCHORS WAS INSERTED AND SUBSEQUENTLY PULLED OUT AND THEREFORE WAS NOT IMPLANTED. THE PROCEDURE WAS COMPLETED WITH SIX AR-3641 2.6 MM KNOTLESS FIBERTAK ANCHORS IMPLANTED. NO OTHER DEVICE MALFUNCTIO

  Patient problems: Unspecified Infection

  MAUDE report 24278908 ↗
• MalfunctionFeb 3, 2026Failure to Advance

  ON 12-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK ANCHORS FAILED TO TENSION. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026. THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION WAS RECEIVED ON 20-JAN-2026: THIS OCCURRED DURING A REMPLISSAGE PROCEDURE. THERE WERE NO REPORTS OF INSTRUMENT OR IMPLANT BREAKAGE. THE CASE WAS COMPLETED USING AR-3636 KNOTLESS 1.8 FIBERTAK SOFT ANCHORS. NO CASE DELAY OCCURRED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250799 ↗
• MalfunctionFeb 3, 2026Failure to Advance

  ON 12-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK ANCHORS FAILED TO TENSION. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026. THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION WAS RECEIVED ON 20-JAN-2026: THIS OCCURRED DURING A REMPLISSAGE PROCEDURE. THERE WERE NO REPORTS OF INSTRUMENT OR IMPLANT BREAKAGE. THE CASE WAS COMPLETED USING AR-3636 KNOTLESS 1.8 FIBERTAK SOFT ANCHORS. NO CASE DELAY OCCURRED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250532 ↗
• MalfunctionDec 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/26/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK ANCHORS EXPERIENCED FAILURE OF THE KNOTLESS MECHANISM. THE ANCHORS WOULD NOT FULLY PULL THROUGH WHEN INTERCONNECTING, AND BOTH ANCHORS SUBSEQUENTLY PULLED OUT. THE ISSUE OCCURRED DURING A GLUTE MEDIUS REPAIR PROCEDURE ON (B)(6) 2025. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 12/08/2025: THE TWO AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK ANCHORS WERE REMOVED FROM THE PATIENT AFTER THE ISSUE OCCURRED. THE CASE WAS COMPLETED USING AR-2324KBCC KNOTLESS BIOCOMPOSITE SWIVELOCK ANCHOR INSTEAD. BONE PREPARATION WAS PERFORMED WITH A PUNCH (AR-3656) AND ITS CORRESPONDING GUIDE. THE SURGEON REPORTED GOOD BONE QUALITY. NO SURGICAL DELAY OR ADDITIONAL ANESTHESIA WAS REQUIRED, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826804 ↗
• MalfunctionDec 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/26/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK ANCHORS EXPERIENCED FAILURE OF THE KNOTLESS MECHANISM. THE ANCHORS WOULD NOT FULLY PULL THROUGH WHEN INTERCONNECTING, AND BOTH ANCHORS SUBSEQUENTLY PULLED OUT. THE ISSUE OCCURRED DURING A GLUTE MEDIUS REPAIR PROCEDURE ON (B)(6) 2025. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 12/08/2025: THE TWO AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK ANCHORS WERE REMOVED FROM THE PATIENT AFTER THE ISSUE OCCURRED. THE CASE WAS COMPLETED USING AR-2324KBCC KNOTLESS BIOCOMPOSITE SWIVELOCK ANCHOR INSTEAD. BONE PREPARATION WAS PERFORMED WITH A PUNCH (AR-3656) AND ITS CORRESPONDING GUIDE. THE SURGEON REPORTED GOOD BONE QUALITY. NO SURGICAL DELAY OR ADDITIONAL ANESTHESIA WAS REQUIRED, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826712 ↗
• InjuryDec 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 11/19/2025, IT WAS REPORTED BY A PATIENT¿S LEGAL REPRESENTATIVE VIA EMAIL THAT THE PATIENT UNDERWENT REPAIR OF THE LEFT GLUTEUS MEDIUS MUSCLE PROCEDURE. DURING THE PROCEDURE, ARTHREX 2.6 KNOTLESS FIBERTAK ANCHORS, PART AND LOT NUMBER UNKNOWN, WERE UTILIZED. FOLLOWING THE INITIAL SURGERY, THE PATIENT DEVELOPED A POST-SURGICAL INFECTION AND SUBSEQUENTLY UNDERWENT A WOUND REVISION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2023, DURING WHICH THE FIBERTAK ANCHORS WERE REMOVED. DESPITE THIS INTERVENTION, THE INFECTION PERSISTED. ON (B)(6) 2024, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO REMOVE SURGICAL HARDWARE FROM A PRIOR LEFT HIP REPLACEMENT PERFORMED IN 2020. THE HARDWARE REMOVAL WAS NECESSARY TO ADDRESS THE ONGOING INFECTION THAT THE PATIENT HAD BEEN SEEKING TREATMENT FOR SINCE THE INITIAL SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 23782733 ↗
• MalfunctionDec 1, 2025Break; Break

  ON 11/11/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK ANCHOR EXPERIENCED AN ISSUE. AFTER COMPLETING THE KNOTLESS MECHANISM, THE SHUTTLE BROKE, REQUIRING THE USE OF AN ADDITIONAL IMPLANT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 11/20/2025: THE IMPLANT AND SUTURES WERE REMOVED FROM THE PATIENT DUE TO THE REPORTED ISSUE. THIS OCCURRED DURING A LATERAL EXTRA-ARTICULAR TENODESIS PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED USING ANOTHER AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK ANCHOR. THERE WAS NO DELAY IN THE PROCEDURE, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23685511 ↗
• MalfunctionOct 30, 2025Material Frayed; Material Frayed

  ON 10/27/2025 A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK® ANCHOR WITH #5SUTURES FAILED, THE SUTURES ON BOTH FRAYED. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2025. THE FIRST DEVICE, THE STITCH FRAYED DURING INSERTION, WAS CUT OUT, AND THE ANCHOR REMAINED IN THE PATIENT. THE SECOND DEVICE WAS USED, AND THE SAME ISSUE OCCURRED: THE STITCH FRAYED DURING INSERTION. THIS SECOND ANCHOR ALSO REMAINED IN THE PATIENT, AND THE STITCH WAS CUT OUT. IN ADDITION, A THIRD AR-3641SP WAS USED IN THE PROCEDURE. DURING THIS PROCEDURE, ONLY ONE OF THESE THREE DEVICES WAS INTENDED TO BE USED. THE PATIENT HAD A GOOD BONE QUALITY THAT WAS PREPPED USING A DRILL. THERE WAS A DELAY OF 10 MINUTES DURING WHICH ADDITIONAL ANESTHESIA WAS ADMINISTERED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23429196 ↗
• MalfunctionOct 30, 2025Material Frayed; Material Frayed

  ON 10/27/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK® ANCHOR WITH #5SUTURES FAILED, THE SUTURES ON BOTH FRAYED. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2025. THE FIRST DEVICE, THE STITCH FRAYED DURING INSERTION, WAS CUT OUT, AND THE ANCHOR REMAINED IN THE PATIENT. THE SECOND DEVICE WAS USED, AND THE SAME ISSUE OCCURRED: THE STITCH FRAYED DURING INSERTION. THIS SECOND ANCHOR ALSO REMAINED IN THE PATIENT, AND THE STITCH WAS CUT OUT. IN ADDITION, A THIRD AR-3641SP WAS USED IN THE PROCEDURE. DURING THIS PROCEDURE, ONLY ONE OF THESE THREE DEVICES WAS INTENDED TO BE USED. THE PATIENT HAD A GOOD BONE QUALITY THAT WAS PREPPED USING A DRILL. THERE WAS A DELAY OF 10 MINUTES DURING WHICH ADDITIONAL ANESTHESIA WAS ADMINISTERED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23428596 ↗
• MalfunctionOct 30, 2025Positioning Failure; Positioning Failure

  ADDITIONAL INFORMATION WAS RECEIVED ON 10/29/2025: THIS WAS AN ARTHROSCOPIC PROCEDURE. THE ISSUE OCCURRED DURING ENGAGEMENT OF THE LOCKING MECHANISM. THE ANCHORS WERE SUCCESSFULLY INSERTED INTO THE HUMERAL HEAD PRIOR TO THE MALFUNCTION. THE SURGERY WAS DELAYED BY APPROXIMATELY 30 TO 45 MINUTES. ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT, ALTHOUGH THE EXACT DURATION IS UNKNOWN. ADVERSE PATIENT EFFECTS HAVE NOT BEEN CONFIRMED YET, BUT A REVISION REMPLISSAGE PROCEDURE MAY BE REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23425622 ↗
• MalfunctionOct 30, 2025Positioning Failure; Positioning Failure

  ADDITIONAL INFORMATION WAS RECEIVED ON 10/29/2025: THIS WAS AN ARTHROSCOPIC PROCEDURE. THE ISSUE OCCURRED DURING ENGAGEMENT OF THE LOCKING MECHANISM. THE ANCHORS WERE SUCCESSFULLY INSERTED INTO THE HUMERAL HEAD PRIOR TO THE MALFUNCTION. THE SURGERY WAS DELAYED BY APPROXIMATELY 30 TO 45 MINUTES. ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT, ALTHOUGH THE EXACT DURATION IS UNKNOWN. ADVERSE PATIENT EFFECTS HAVE NOT BEEN CONFIRMED YET, BUT A REVISION REMPLISSAGE PROCEDURE MAY BE REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23425418 ↗
• MalfunctionOct 27, 2025Break; Break

  ON 10/15/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK ANCHOR WITH #5 SUTURE EXPERIENCED AN ISSUE AFTER INSERTING THE IMPLANT INTO THE BONE HOLE, IT WAS NOTICED THAT THE SUTURE HAD BROKEN. A REPLACEMENT AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK ANCHOR WITH #5SUTURE WAS USED TO COMPLETE THE CASE. NO SPECIFIC DETAILS WERE PROVIDED REGARDING THE TYPE OF SURGERY, BONE PREPARATION, OR BONE QUALITY. THERE WAS NO SIGNIFICANT DELAY, NO ADDITIONAL ANESTHESIA ADMINISTERED, AND NO ADVERSE EFFECTS NOTED. NO PHOTOGRAPHS WERE TAKEN TO DOCUMENT THE EVENT. THE ISSUE WAS IDENTIFIED ON (B)(6) 2025, WITH NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025: ALL BROKEN SUTURES FROM THE AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK ANCHOR WITH #5 SUTURE WERE REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392090 ↗
• MalfunctionOct 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT (QTY. 2) AR-3641SP SELF-PUNCHING KNOTLESS FIBERTAK ANCHORS DID NOT REMAIN FIXED IN PLACE AFTER BEING INSERTED DURING A SHOULDER ARTHROSCOPY. THE GUIDE WAS USED WITH THE 2.6MM DRILL. THE BONE QUALITY WAS NOT PROVIDED, AND NO INSTRUMENT WAS BROKEN. THE PROCEDURE WAS COMPLETED BY OPENING TWO ANCHORS OF THE SAME REFERENCE WITHIN THE STIPULATED TIMEFRAME. NO LOCAL ANESTHETIC WAS USED; ONLY GENERAL ANESTHESIA WAS USED. THE MEDICAL TEAM REPORTED NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357159 ↗
• MalfunctionOct 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT (QTY. 2) AR-3641SP SELF-PUNCHING KNOTLESS FIBERTAK ANCHORS DID NOT REMAIN FIXED IN PLACE AFTER BEING INSERTED DURING A SHOULDER ARTHROSCOPY. THE GUIDE WAS USED WITH THE 2.6MM DRILL. THE BONE QUALITY WAS NOT PROVIDED, AND NO INSTRUMENT WAS BROKEN. THE PROCEDURE WAS COMPLETED BY OPENING TWO ANCHORS OF THE SAME REFERENCE WITHIN THE STIPULATED TIMEFRAME. NO LOCAL ANESTHETIC WAS USED; ONLY GENERAL ANESTHESIA WAS USED. THE MEDICAL TEAM REPORTED NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357155 ↗