Arthrex® AR-3652TSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888867362925), received between Nov 21, 2023 and Jul 30, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Loosening of Implant Not Related to Bone-Ingrowth

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50084534 ↗
• MalfunctionFeb 27, 2026Device Dislodged or Dislocated

  ON 10-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TSP FIBERTAK RC ANCHOR PULLED OUT. THE CASE WAS COMPLETED USING A 4.75 MM SWIVELOCK FOR FIXATION. THIS ISSUE WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 13-FEB-2026: THE ANCHOR WAS REMOVED, AND THE CASE WAS COMPLETED WITH AN AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK SUTURE ANCHOR, DOUBLE LOADED 4.75 X 22 MM, 5PCS. THERE WAS NO CASE DELAY AND NO ADDITIONAL ANESTHESIA ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 24472516 ↗
• MalfunctionJan 22, 2026Device Dislodged or Dislocated

  ON (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3652TSP FIBERTAK RC SUTURE ANCHOR EXPERIENCED AN ISSUE DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PERFORMED ON (B)(6) 2026. THE FIBERTAK RC ANCHOR WAS INSERTED INTO BONE USING A 2.6 MM RC SLEEVE VIA THE SELF-PUNCHING METHOD. INITIAL RETENTION TESTING CONFIRMED THE ANCHOR WAS SECURE. HOWEVER, AFTER SUTURE PASSAGE WITH A SCORPION HD, THE ANCHOR DISLODGED FROM THE BONE WHILE THE SURGEON WAS TYING A KNOT WITH THE SLIDING 1.3 MM TAPE. THE ANCHOR WAS SUBSEQUENTLY REPLACED WITH A 4.75 MM SWIVELOCK. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED ON 13-JAN-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146790 ↗
• MalfunctionJan 15, 2026Device Dislodged or Dislocated

  ON 30-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-3652TSP FIBERTAK RC SUTURE ANCHOR PULLED OUT DURING USE WHILE BEING SET. THE SURGEON REPOSITIONED AND PLACED A NEW ANCHOR TO ACHIEVE FIXATION. THE CASE WAS DELAYED BY APPROXIMATELY ONE MINUTE. THIS OCCURRED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 02-JAN-2026: ALL MATERIAL FROM THE IMPLANT WAS REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH AN AR-3652SP FIBERTAK RC SUTURE ANCHOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24081549 ↗
• MalfunctionDec 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 17TH NOV 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-3652TSP, FIBERTAK® RC SUTURE ANCHOR, (BLUE), AND 1 UNIT OF AR-3653SP, KNOTLESS 2.6 FIBERTAK® RC SOFT ANCHOR, 1.7 MM TIGERTAPE¿ LOOP(WHITE/BLACK), #2 TENSIONABLE SUTURE (BLUE), SELF-PUNCHING, QTY. 5, THE AR-3652TSP WAS MISALIGNED DURING USE. AR-3653SP WAS CHANGED TO AND THE SURGEON USED THE DRILL AND SLEEVE, BUT THE ANCHOR WAS STILL PULLED OUT. THIS WAS DETECTED DURING AN INSTABILITY PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY OPENING ANOTHER TYPE OF ANCHOR.

  Patient problems: Insufficient Information

  MAUDE report 23719730 ↗
• MalfunctionMay 22, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 04/26/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT (2) AR-3652TSP FIBERTAK® RC SUTURE ANCHORS BENT UPON INSERTION. THIS OCCURRED DURING A SHOULDER ARTHROSCOPY WHERE OTHER ANCHORS WERE USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 19378569 ↗
• MalfunctionMay 21, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 04/26/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT (2) AR-3652TSP FIBERTAK® RC SUTURE ANCHORS BENT UPON INSERTION. THIS OCCURRED DURING A SHOULDER ARTHROSCOPY WHERE OTHER ANCHORS WERE USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 19367372 ↗
• MalfunctionMay 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 04/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TSP FIBERTAK RC PULLED OUT. THE ANCHOR WAS PLACED IN THE POSTERIOR ASPECT OF THE GREATER TUBEROSITY THROUGH AN AR-1941DS KNOTLESS CORKSCREWS DISPOSABLE INSTRUMENT KIT IN A SELF-PUNCHING MANNER. NO DECORTICATION WAS DONE IN PREP. THE SUTURETAPES WERE PASSED FIRST POSTERIORLY ONE AT A TIME, AND THEN THE SWEDGED FIBERTAPES WERE PASSED TOGETHER LASTLY FROM A POSTERIOR TO ANTERIOR DIRECTION. THERE WAS AN ADDITIONAL ANTERIOR FIBERTAK PLACED AND PASSED SIMILARLY. UPON PLACING HALF OF THESE SUTURES INTO THE LATERAL ROW OF AN AR-2323KPSLC PEEK KNOTLESS SWIVELOCK, THE ANCHOR POPPED OFF OF THE BONE WHEN PULLING TENSION ON THE SUTURES. THERE WAS NO EXCESSIVE FORCE BEING PULLED, AND THE SUTURES JUST HAD THE SLACK TAKEN OUT, NOTHING MORE. THIS HAPPENED BEFORE THE LATERAL SWIVELOCK WAS STARTED INTO THE BONE. THE ANCHOR AND ALL OF ITS SUTURES WERE RETRIEVED IN ITS ENTIRETY. THE PATIENT WAS NOT HARMED. A 5.5MM SWIVELOCK, LOADED WITH TAPES, WAS OPENED AND PLACED IN THE HOLE THE FIBERTAK CAME OUT OF. SUFFICIENT PURCHASE WAS ACHIEVED, AND THE CASE WAS COMPLETED. THE CASE WAS DELAYED FIFTEEN MINUTES. THIS WAS DISCOVERED D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326112 ↗
• MalfunctionMay 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 19277680 ↗
• MalfunctionApr 24, 2024Defective Device; Defective Device

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06527607 THAT AN AR-3652TSP FIBERTAK RC SUTURE ANCHOR HAD THE SUTURE TIP "MESSED UP", AND NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175182 ↗
• MalfunctionApr 15, 2024Defective Device; Defective Device

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TSP FIBERTAK RC SUTURE ANCHOR, BLUE, AND AN AR-3652SP FIBERTAK RC SUTURE ANCHOR, WHITE/BLACK, FAILED DURING A PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19111874 ↗
• MalfunctionApr 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 12/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TSP FIBERTAK HAD AN ISSUE. THIS OCCURRED ON (B)(6) 2022 DURING A RCR PROCEDURE WITH NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION RECEIVED ON 12/14/2022: AR-3652TSP FIBERTAK ANCHOR PULLED OUT AFTER INSERTION. THE ANCHOR WAS RETRIEVED FROM PATIENT AND THE CASE WAS COMPLETED USING A 2324BCT-2 BIOCOMPOSITE SWIVELOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077941 ↗
• MalfunctionFeb 27, 2024Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 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 18793960 ↗
• MalfunctionJan 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 12/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652TSP FIBERTAK RC ANCHOR PULLED OUT WHEN TRYING THE KNOTS. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING A SWIVELOCK. THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552088 ↗
• MalfunctionDec 20, 2023Break; Break

  ON 11/22/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-3652TSP FIBERTAK RC AND AN AR-3652TSP FIBERTAK RC PULLED OUT OR BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18368939 ↗
• InjuryNov 21, 2023Break; Break

  MEDICAL RECORDS RECEIVED ON (B)(6) 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 PASSER WA

  Patient problems: Foreign Body In Patient

  MAUDE report 18182629 ↗