Arthrex® AR-3642SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888867426429), received between Apr 17, 2024 and Feb 9, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE SHOULDER ARTHROSCOPY, THE SHUTTLE SUTURE OF THE DEVICE WAS IMPALED AND COULD NOT BE PULLED THROUGH. 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 24290966 ↗
• MalfunctionJan 19, 2026Break

  ON 02-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, TWO AR-3642SP KNOTLESS 2.6 FIBERTAK DOUBLE LOADED ANCHORS WITH #2 KL REPAIR SUTURES WERE IMPLANTED. BOTH SHUTTLING LOOPS BROKE ON EACH ANCHOR AFTER IMPLANTATION. THE ANCHORS REMAINED IN SITU, AND THE BROKEN SUTURES WERE REMOVED. TWO ADDITIONAL AR-3642SP ANCHORS FROM A DIFFERENT LOT WERE UTILIZED WITHOUT ISSUE TO COMPLETE THE CASE. THERE WAS NO SURGICAL DELAY, NO ADDITIONAL ANESTHESIA ADMINISTERED, AND NO PATIENT HARM REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24108248 ↗
• MalfunctionJan 19, 2026Break

  ON 02-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, TWO AR-3642SP KNOTLESS 2.6 FIBERTAK DOUBLE LOADED ANCHORS WITH #2 KL REPAIR SUTURES WERE IMPLANTED. BOTH SHUTTLING LOOPS BROKE ON EACH ANCHOR AFTER IMPLANTATION. THE ANCHORS REMAINED IN SITU, AND THE BROKEN SUTURES WERE REMOVED. TWO ADDITIONAL AR-3642SP ANCHORS FROM A DIFFERENT LOT WERE UTILIZED WITHOUT ISSUE TO COMPLETE THE CASE. THERE WAS NO SURGICAL DELAY, NO ADDITIONAL ANESTHESIA ADMINISTERED, AND NO PATIENT HARM REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24108223 ↗
• MalfunctionDec 22, 2025Break; Break

  ON 12/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3642SP 2.6 DL KNOTLESS FIBERTAK WAS FAULTY. AFTER PASSING THE FIRST REPAIR STITCH AND RETRIEVING THE WORKING PORTAL WITH SCORPION, THE SUTURE BROKE OFF FROM THE ANCHOR AT THE BASE (NOT AT THE END BY SCORPION). THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS PROVIDED BY THE REP ON 12/4/25. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR OF SUPRASPINATUS. NO INSTRUMENT WAS USED TO PREPARE THE BONE SOCKET. REPORTED BONE QUALITY WAS GOOD. THE BLUE REPAIR SUTURE BROKE BUT IT WAS RETRIEVED IN ONE PIECE.

  Patient problems: Insufficient Information

  MAUDE report 23865074 ↗
• MalfunctionDec 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/20/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3642SP KNOTLESS 2.6 FIBERTAK DOUBLE LOADED ANCHOR BECAME DISLODGED AFTER INSERTION DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR. THE ANCHOR WAS INSERTED PERCUTANEOUSLY USING AN AR-1941DGF GUIDE. AFTER INSERTION AND REMOVAL OF THE INSERTER AND GUIDE, THE SHEATH OF THE ANCHOR WAS VISIBLE ABOVE THE BONE. WHEN LIGHT TENSION WAS APPLIED, THE ANCHOR DISLODGED FROM THE BONE. THE ENTIRE ANCHOR AND ITS CONTENTS WERE REMOVED FROM THE PATIENT. NO ADDITIONAL PARTS WERE USED, AND THE DOG EAR WAS LEFT UNTREATED. THE CASE WAS DELAYED BY APPROXIMATELY 2 MINUTES FOR ASSESSMENT, AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO PHOTOS WERE TAKEN OF THE EVENT. THIS OCCURRED DURING USE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 23757634 ↗
• MalfunctionNov 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3642SP KNOTLESS FIBERTAK ANCHOR PULLED OUT AS THEY WENT TO SHUTTLE THE SUTURE THROUGH IT. THIS WAS DISCOVERED DURING A SHOULDER SCOPE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657055 ↗
• MalfunctionOct 29, 2025Break; Break

  ON 10/17/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2350 KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS AND AN AR-3642SP KNOTLESS FIBERTAK EXPERIENCED A MALFUNCTION. WHEN IMPLANTING THE TENSION-TIGHT BUTTON, FLIPPING THE BUTTON, AND ADDING TENSION, THE SUTURE MADE A CLEAN BREAK AT THE BUTTON. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413303 ↗
• MalfunctionSep 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER 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 23073459 ↗
• MalfunctionSep 5, 2025Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  ON 08/18/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3642SP KNOTLESS 2.6 FIBERTAK® DOUBLE LOADED W/ #2 KL REPAIR SUTURES WERE DAMAGED. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2025. THE REPAIR SUTURE AND LOOP SUTURE WERE FOUND TO BE INTERTWINED, AND THE SUTURE WOULD NOT SHUTTLE. THE ANCHOR REMAINED IN THE PATIENT, AND THE SUTURES WERE REMOVED. THIS RESULTED IN A 15-MINUTE DELAY.

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

  MAUDE report 22979280 ↗
• MalfunctionApr 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 4/2/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3642SP KNOTLESS 2.6 FIBERTAK HAD AN ISSUE DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON SHUTTLED THE TWO SUTURES THROUGH THE ANCHOR, THE SHUTTLE SUTURE COULD NOT BE LOOPED THROUGH AND RIPPED APART INSIDE THE PATIENT. THE SUTURES WERE CUT AND REMOVED, AND THE ANCHOR REMAINED IN ONE PIECE INSIDE THE PATIENT. NOTHING ELSE BROKE INSIDE THE PATIENT, AND THERE WAS NO HARM. ANOTHER AR-3642SP KNOTLESS 2.6 FIBERTAK WITH THE SAME LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A 1-MINUTE CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 21865740 ↗
• MalfunctionJan 16, 2025Break; Break

  ON 12/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3642SP KNOTLESS 2.6 FIBERTAK BROKE WHEN THE SURGEON ATTEMPTED TO SLIDE THE SHUTTLE STITCH BACK AND FORTH BEFORE PASSING REPAIR STITCHES. THE REST OF THE ANCHOR WAS PULLED OUT AND PROCEEDED BY USING A PRODUCT FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING A BICEPS TENODESIS PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 1/6/2025: THE ANCHOR ALONG WITH ALL BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT. THE CASE WAS DELAYED A FEW MINUTES WHILE IMPLANTING THE NEW PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168406 ↗
• MalfunctionOct 14, 2024Defective Device; Defective Device

  ON 10/4/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-3642SP KNOTLESS 2.6 FIBERTAK HAD THE TAILS SHOWING OUT OF THE BONE AS WELL AS THE KNOTLESS MECHANISM. BOTH AR-3642SP KNOTLESS 2.6 FIBERTAK HAD TO BE CUT OUT AND A 5.5 SWIVELOCK WAS INSERTED IN PLACE TO COMPLETE THE CASE. SOME OF THE ANCHORS IS STILL IN THE PATIENT'S BONE. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 20441172 ↗
• MalfunctionOct 14, 2024Break; Defective Device; Break; Defective Device

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-3642SP KNOTLESS 2.6 FIBERTAK HAD THE TAILS SHOWING OUT OF THE BONE AS WELL AS THE KNOTLESS MECHANISM. BOTH AR-3642SP KNOTLESS 2.6 FIBERTAK HAD TO BE CUT OUT AND A 5.5 SWIVELOCK WAS INSERTED IN PLACE TO COMPLETE THE CASE. SOME OF THE ANCHORS IS STILL IN THE PATIENT'S BONE. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 20441047 ↗
• MalfunctionApr 17, 2024Break; Break

  ON 03/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3642SP KNOTLESS 2.6 FIBERTAK PASSING SUTURE BROKE WHEN SHUTTLING REPAIR STITCHES THROUGH THE ANCHOR. EVERYTHING WAS REMOVED AND A NEW ANCHOR WAS PLACED IN THE SAME HOLD AFTER REDRILLING. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 3/27/2024: THIS WAS DISCOVERED DURING A SHOULDER PROCEDURE AND COMPLETED USING ANOTHER AR-3642SP KNOTLESS 2.6 FIBERTAK. THE PROCEDURE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NECESSARY.

  Patient problems: Insufficient Information

  MAUDE report 19126243 ↗