Arthrex® AR-3652TTSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00888867362949), received between Jul 10, 2023 and Apr 10, 2026 — classified as 1 injury, 23 malfunctions.

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

• MalfunctionApr 10, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE ROTATOR CUFF SURGERY, THE IMPLANT BECAME DISLODGED FROM THE BONE AFTER IT HAD BEEN INSERTED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (SWIVELOCK ANCHOR). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845035 ↗
• MalfunctionApr 10, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE ROTATOR CUFF SURGERY, THE IMPLANT BECAME DISLODGED FROM THE BONE AFTER IT HAD BEEN INSERTED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (SWIVELOCK ANCHOR). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839357 ↗
• MalfunctionFeb 10, 2026Break

  ON 21-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TTSP FIBERTAK RC WAS USED DURING A PROCEDURE, AND THE SUTURE TAPE WAS SNAPPING. THIS ISSUE WAS DISCOVERED INTRAOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED ON 02-FEB-2026: ON (B)(6) 2025, DURING A ROTATOR CUFF REPAIR PROCEDURE, THE SUTURE TAPE SNAPPED INTRAOPERATIVELY WHILE INSIDE THE PATIENT. THE SUTURE TAPE AND ALL ASSOCIATED FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING A REPLACEMENT AR-3652TTSP FIBERTAK RC SUTURE ANCHOR. THE PROCEDURE EXPERIENCED AN APPROXIMATE 10-MINUTE DELAY, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 24306319 ↗
• MalfunctionNov 25, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A KNEE SURGERY WHEN THE FIBER TAK WAS INSERTED IT BECAME BENT. 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 23645285 ↗
• MalfunctionOct 15, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 10/14/2025: THE SURGERY WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303556 ↗
• MalfunctionJul 21, 2025Failure to Advance; Failure to Advance

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3652TTSP FIBERTAK RC SUTURE ANCHOR FAILED TO DEPLOY DURING A ROUTINE ROTATOR CUFF REPAIR PROCEDURE FOR A SUPRASPINATUS TEAR ON (B)(6) 2025. UPON INSPECTION, THE ANCHOR¿S SHEATH EXHIBITED RESISTANCE TO BUNCHING AND DEPLOYMENT. THERE WAS NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 07/10/2025: THE CASE WAS COMPLETED AS PLANNED WITH ANOTHER AR-3652TTSP FIBERTAK RC SUTURE ANCHOR. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556917 ↗
• MalfunctionNov 6, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 10/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TTSP FIBERTAK RC INSERTER BENT WHILE IT WAS MALLETED INTO THE BONE. THE ANCHOR DID NOT MAKE IT INTO THE BONE AND WAS UNABLE TO BE USED DUE TO THE INSERTED BENDING. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 10/30/2024: THIS WAS DISCOVERED DURING AN RCR PROCEDURE. THE CASE WAS COMPLETED USING ANOTHER AR-3652TTSP FIBERTAK RC. THE CASE WAS DELAYED APPROXIMATELY ONE TO TWO MINUTES. ENOUGH ANESTHESIA WAS ADMINISTERED FOR THOSE EXTRA MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620555 ↗
• MalfunctionNov 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3652TTSP FIBERTAK® RC SUTURE ANCHOR BACKED OUT. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2024 WHEN THEY PUT 3 FIBERTAKS IN A ROW AND REMOVED THE DEVICE THE IMPLANT BACKED OUT. THE CASE CONTINUED USING ANOTHER AR-3652TTSP. THERE WAS A 45-SECOND DELAY. THE PATIENT HAD A GOOD BONE THAT WAS DEBRIDED AND THE SELF-PUNCH WAS UTILIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612534 ↗
• MalfunctionSep 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 08/16/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TTSP FIBERTAK RC PULLED OUT OF THE BONE. THE PATIENT WAS NOT AFFECTED, AND THE CASE WAS NOT DELAYED. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20161051 ↗
• MalfunctionJun 20, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 05/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3652TTSP SUTURE ANCHOR WAS USED WITHOUT A GUIDE AND THE SHAFT BENT, WAS UNABLE TO SELF PUNCH THROUGH THE BONE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19579640 ↗
• MalfunctionJun 19, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 11/16/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-3652TTSP FIBERTAK® RC SUTURE ANCHORS SUTURE IS MISALIGNED AND WILL NOT WORK. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2022 WHEN THE TRAP AT THE BOTTOM SEEMED TO HAVE MISALIGNED SUTURES. THE IMPLANT WAS REMOVED AS THE DEVICE WAS DECLARED UNUSABLE, AND A NEW ANCHOR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570400 ↗
• MalfunctionJun 19, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 05/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3652TTSP FIBERTAK® RC SUTURE ANCHOR BENT. THIS OCCURRED DURING A CASE, WHEN PUT TO USE THE SHAFT BENT COMPLETELY, AND THE ANCHOR COULD NOT BE INSERTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19570102 ↗
• MalfunctionJun 5, 2024Failure to Advance; Failure to Advance

  ON 6/9/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TTSP FIBERTAK RC SUTURE ANCHOR WAS NOT ABLE TO BE FIXED AND WAS SLIDING FREELY THROUGH THE ANCHOR. THEN, WHILE IMPLANTING AN AR-3652TSP FIBERTAK RC SUTURE ANCHOR, BLUE, AND AN AR-3652SP FIBERTAK RC SUTURE ANCHOR, WHITE AND BLACK, BOTH PULLED OUT OF IMPLANTATION SITE. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION REQUESTED. WHEN THE FIBERTAK RC SUTURE ANCHOR WAS NOT ABLE TO BE FIXED, SURGEON CUT OUT THE SUTURES AND REMOVED THE ANCHOR. A 4.75 SWIVELOCK WAS OPENED AND USED SUCCESSFULLY. WHEN AR-3652TSP PULLED OUT, SURGEON COMPLETELY REMOVED IT AND USED AN AR-3652SP, HOWEVER, THIS ONE TOO PULLED OUT. SURGEON COMPLETELY REMOVED ALL REMAINING SUTURES AND USED ANOTHER 4.75 SWIVELOCK TO COMPLETE THE CASE. ALSO, A SPEEDBRIDGE CONSTRUCT AND ADDITIONAL CUFFMEND AUGMENTATION WAS USED TO COMPLETE THE CASE. NOTHING BROKE INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472479 ↗
• MalfunctionJun 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED ON 08/31/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TTSP SUTURE ANCHOR PULLED OUT OF THE BONE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446778 ↗
• MalfunctionMay 25, 2024Failure to Advance; Failure to Advance

  ON 1/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TTSP FIBERTAK RC SUTURE ANCHOR WOULD NOT DEPLOY CORRECTLY AND PULLED OUT OF IMPLANTATION SITE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19398621 ↗
• MalfunctionFeb 28, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE ANCHOR TIP WAS RIFFLED OFF. 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 18795856 ↗
• MalfunctionFeb 27, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 02/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3652TSP FIBERTAK® RC SUTURE ANCHOR, AND AN AR-3652TTSP FIBERTAK® RC SUTURE ANCHOR BENT, AND AN AR-3650DS DISPOSABLES KIT WAS WASTED. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2024 THE FIRST ANCHOR, AR-3652TSP WAS A SELF-PUNCH AND WHEN ATTEMPTING TO INSERT IT WAS BENT. THEN AR-3652TTSP AR-3652TTSP PUNCHED A HOLE AND TRIED TO INSERT WHICH RESULTED IN A BEND. THEN DRILL BIT WAS USED TO ATTEMPT TO MAKE A BIGGER HOLE YET THE ANCHOR WOULD STILL NOT GO IN. AN AR-3650DS KIT WAS USED IN THIS CASE AND WASTED. THE PATIENT HAD A HARD BONE. THE CASE WAS COMPLETED USING AN AR-2324BCCTT SUTURE ANCHOR.

  Patient problems: Insufficient Information

  MAUDE report 18794011 ↗
• MalfunctionFeb 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 2/2/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TTSP 2.6 FIBERTAK SUTURE ANCHOR WAS DISLODGED. THIS OCCURRED WHEN THE ANCHOR WAS IMPLANTED AND AFTER SUTURES WERE PASSED THROUGH ROTATOR CUFF SURGEON WAS TENSIONING WHILE PLACING LATERAL ROW SWIVELOCK THE 2.6 FIBERTAK DISLODGED. THREE MEDIAL ROW ANCHORS WERE ORIGINALLY IMPLANTED, SURGEON REMOVED THE 2.6 FIBERTAK THAT PULLED OUT AND COMPLETED REPAIR WITH REMAINING ANCHORS. NO PIECES BROKE INSIDE THE PATIENT. THIS WAS DISCOVERED DURING AN ROTATOR CUFF REPAIR PROCEDURE (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18769451 ↗
• MalfunctionJan 12, 2024Material Frayed; Material Frayed

  ON 12/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TTSP FIBERTAK RC SUTURE SHREDDED WHILE BEING PULLED WITH A FIBERTAPE RETRIEVER. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED INDICATES THAT ALL THE BROKEN SUTURES WERE REMOVED FROM INSIDE THE PATIENT, AND THE CASE WAS COMPLETED USING AN AR-2324BCCTT BIOCOMPOSITE SWIVELOCK C. THE CASE WAS NOT DELAYED, AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507616 ↗
• MalfunctionJan 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED ON 09/13/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TTSP FIBERTAK SUTURE WAS RIPPED. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18452778 ↗
• MalfunctionDec 6, 2023Unintended Movement; Unintended Movement

  ON 11/6/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TTSP FIBERTAK RC SWEDGE SUTURE WASN'T SECURE, WHICH RESULTED IN THE SUTURE SLIDING AND MAKING THE SINGLE PASS THROUGH THE ROTATOR CUFF TISSUE CHALLENGING. TO COMPLETE THE REPAIR, THE SURGEON CUT THE SWEDGE AND PASSED THE TAILS INDIVIDUALLY. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18276931 ↗
• InjuryNov 21, 2023Break; Break

  MEDICAL RECORDS RECEIVED ON DECEMBER 13, 2023 INDICATE THAT A SMALL RETAINED METALLIC FRAGMENT CONSISTING OF THE TIP OF AN ARTHREX SCORPION SUTURE PASSER BROKE WHILE ATTEMPTING TO PASS SUTURES THROUGH THE THICKENED SUPRASPINATUS TENDON RESULTING IN SMALL RETAINED METALLIC FRAGMENT IMBEDDED IN CUFF TISSUE. PRIOR TO THE SURGERY RISKS AND BENEFITS WERE THOROUGHLY DISCUSSED WITH THE PATIENT. IT WAS ALSO EXPLAINED TO THE PATIENT THAT THERE WAS AN INCREASED DIFFICULTY LEVEL DUE TO THE SIGNIFICANT SIZE OF THE PATIENT¿S SHOULDER. THE OPERATIVE REPORT INDICATED THAT DUE TO THE SIGNIFICANT SOFT TISSUE SIZE OF THE PATIENT, IT WAS FELT THAT THE MAJORITY OF THIS PROCEDURE SHOULD BE PERFORMED ARTHROSCOPICALLY, AS IT WOULD BE SIGNIFICANTLY DIFFICULT TO PASS SUTURES INTO THE RETRACTED CUFF TISSUE FROM THE MINI OPEN INCISION. THE OPERATIVE REPORT ALSO NOTED: UPON PASSING SUTURES IN THE THICKENED PORTION OF THE MID-TO-POSTERIOR SUPRASPINATUS TENDON, IT WAS NOTED THAT DUE TO THE THICKNESS OF TENDON, THE SCORPION SUTURE PASSER HAD DIFFICULTY PASSING THE NEEDLE SHUTTLING SUTURE THROUGH THE TISSUE. THIS WAS NOTED TO SKIVE MEDIALLY AND NOT PENETRATE THE SUPERIOR SURFACE OF THE CUFF TISSUE, THE SUTURE PAS

  Patient problems: Foreign Body In Patient

  MAUDE report 18182656 ↗
• MalfunctionNov 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/19/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TTSP FIBERTAK RC PULLED OUT OF THE IMPLANTATION SITE. THIS WAS DISCOVERED AFTER THE ANCHOR WAS IMPLANTED AND THE SURGEON PASSED ALL THE SUTURES THROUGH THE ROTATOR CUFF AND BEGAN TO TIE THE SLIDING SUTURE TAPS FROM THE ANCHOR. THE CASE WAS AN RCR PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING A SWIVELOCK. ADDITIONAL INFORMATION RECEIVED ON 10/19/2023: AN AR-2324KPSLC PEEK KNOTLESS SWIVELOCK AND AR-7237-7 FIBERTAPE WERE USED TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 18138510 ↗
• MalfunctionJul 10, 2023Material Twisted/Bent; Material Twisted/Bent

  ON 6/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TTSP FIBERTAK RC INSERTER BENT DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE AND COMPLETED USING AN AR-3652TSP FIBERTAK RC. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17287066 ↗