Arthrex® AR-3652SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00888867362901), received between Jul 11, 2022 and Sep 9, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Device Dislodged or Dislocated

  On 26th August 2026, it was reported by an Arthrex employee via email that for an AR-3652SP, FiberTak® RC Suture Anchor, (White/Black), the anchor dislodged upon insertion into the medial aspect of the femoral head. This was detected during use in an unknown procedure on (b)(6) 2026. The procedure was completed successfully as an alternative product (detail unknown) was opened and inserted at a different location, where it was successfully seated without issue.No significant surgery delay reported. All of the product/fragment was removed, and nothing remains in the patient. No additional anesthesia administered to the patient. No information about an instrument used to prepare/tap the bone socket for insertion of the implant. Bone quality of the patient is unknown.

  Patient problems: Insufficient Information

  MAUDE report 50690421 ↗
• MalfunctionFeb 4, 2026Positioning Failure

  ON 14-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3652SP FIBERTAK RC SUTURE ANCHOR EXPERIENCED AN ISSUE DURING USE. DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR ON (B)(6) 2026, THE ANCHOR WAS INSERTED INTO THE GREATER TUBEROSITY AND SECURED AS INTENDED. UPON SECURING THE IMPLANT, THE SURGEON OBSERVED THAT THE SWAGED 1.7 MM SUTURETAPE SLID WITHIN THE ANCHOR, WHILE THE 1.3 MM SUTURETAPE REMAINED STATIC AND DID NOT SLIDE. THE ANCHOR ITSELF REMAINED SECURE AND MAINTAINED ITS POSITION, ALLOWING THE SURGEON TO PROCEED WITH THE REPAIR USING THE SUTURES FROM THE ANCHOR. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 19-JAN-2026: AFTER INSERTION OF THE ANCHOR, WHILE POSITIONING THE SUTURES FOR PASSAGE THROUGH THE CUFF, THE SURGEON NOTED THAT THE 1.7 SUTURETAPE WAS SLIDING RATHER THAN THE 1.3 SUTURETAPE. NO FRAYING, LOOSENING, OR SEPARATION OF THE SUTURE WAS OBSERVED. THE PROCEDURE WAS COMPLETED USING AR-3652 FIBERTAK RC SUTURE ANCHORS, WITH ADDITIONAL ARTHREX SWIVELOCK IMPLANTS USED. THERE WAS NO CASE DELAY OR ADDITIONAL ANESTHESIA ADMINISTERED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 24257670 ↗
• MalfunctionFeb 3, 2026Material Twisted/Bent

  ON 14-JAN-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-3652SP FIBERTAK ANCHOR WAS BENDING AND COULD NOT BE PLACED. THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248938 ↗
• MalfunctionOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 8TH OCTOBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-3652SP, FIBERTAK® RC SUTURE ANCHOR, (WHITE/BLACK), THE FIBERTAK RC ANCHOR WAS PLACED INTO BONE (MEDIAL ROW OF ROTATOR CUFF REPAIR) AND SET. SURGEON SLID OUT THE SLIDING SUTURE FROM THE ANCHOR AND FOUND HE HAD SOME RESISTANCE. HE PULLED QUITE HARD AND ENDED UP PULLING ANCHOR OUT OF BONE. HE FOUND OUT AS HE LOOKED AT THE ANCHOR MORE CLOSELY THAT THERE WAS A LITTLE KNOT TOWARD THE END OF THE SUTURE TAPE. HE PRESUMED THAT THE RESISTANCE WAS DUE TO THE KNOT AS IT WAS TRYING TO BE PASSED THROUGH THE SOCK CAUSED THE ANCHOR TO PULL OUT OF THE BONE. THIS WAS DETECTED DURING USE IN A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER ANCHOR WAS INSERTED. (B)(6) 2025 - THE COMPLAINT INITIATOR CLARIFIED THAT NO IMPLANT DID DEPLOY SUCCESSFULLY, IT WAS AS THE SURGEON TRIED SLIDING OUT THE TAPE THAT THE ANCHOR PULLED OUT BECAUSE OF THE TINY KNOT AT THE END OF THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299863 ↗
• MalfunctionAug 29, 2025Positioning Failure; Positioning Failure

  ON 08/12/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-3652SP KNOTLESS 2.6 FIBERTAK® DOUBLE LOADED W/ #2 KL REPAIR SUTURES WHEN PLACING IT INTO THE HANDLE, BUT IT DIDN¿T GO IN. THIS OCCURRED DURING A PROXIMAL BICEPS TENODESIS. THEY USED THE HANDLE AND THE DRILL BIT DESIGNED FOR THIS ANCHOR (DISPOSABLE), PLACING IT INTO THE HANDLE, BUT IT DIDN¿T GO IN. SINCE THE SURGEON COULDN¿T PLACE THE FIRST ONE, THEY GAVE HIM ANOTHER, AND WITH THAT ONE, HE SLIGHTLY CHANGED THE DIRECTION AND DRILLED THE BONE MULTIPLE TIMES. ADDITIONALLY, HE PLACED THE SECOND ANCHOR WITHOUT INSERTING IT INTO THE HANDLE.

  Patient problems: Insufficient Information

  MAUDE report 22923485 ↗
• MalfunctionFeb 24, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE FIBER WAS UNTANGLED. 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. ON (B)(6) 2025: RECEIVED FURTHER INFORMATION THAT THE FIBER UNRAVELED WHILE BEING INSERTED INTO THE PATIENT, BUT IT DID NOT REMAIN IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445598 ↗
• MalfunctionJul 8, 2024Defective Device; Defective Device

  ON 6/13/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3652SP FIBERTAK RC SUTURE ANCHOR HAD AN ISSUE DURING A ROTATOR CUFF PROCEDURE ON (B)(6) 2024. AFTER THE INSERTION OF THE COMPLAINT DEVICE INTO THE PATIENT, WHEN A CAMERA WAS BROUGHT IN, IT LOOKED LIKE THE FORK TIP IN THE MIDDLE HAD ALMOST PIERCED THROUGH THE SUTURE ANCHOR. THE SUTURE ANCHOR WAS STILL ON THE INSERTER AT THAT POINT, AND EVERYTHING WAS REMOVED FROM THE PATIENT IN ONE PIECE. NOTHING BROKE INSIDE THE PATIENT. ANOTHER AR-3652SP FIBERTAK RC SUTURE ANCHOR WITH THE SAME LOT NUMBER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO HARM TO THE PATIENT. THE NEW SUTURE ANCHOR WAS CHECKED BEFORE INSERTION INTO THE PATIENT AND WAS FULLY FUNCTIONAL. A 5-MINUTE CASE DELAY WAS REPORTED BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE COMPLAINT DEVICE WAS DISCARDED AND NO PICTURES WERE TAKEN. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19688675 ↗
• 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 19277505 ↗
• MalfunctionMay 8, 2024Device Damaged by Another Device; Device Damaged by Another Device

  ON 11/25/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3652SP ANCHOR INSERTER BROKE THE ANCHOR INSIDE ITSELF AND COULD NOT DEPLOY DURING INSERTION. THIS OCCURRED DURING A ROTATOR CUFF REPAIR WITH NO PATIENT AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267649 ↗
• MalfunctionApr 26, 2024Defective Device; Defective Device

  ON 5/31/2022, 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 19194095 ↗
• MalfunctionDec 21, 2023Break; Break

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

  Patient problems: Insufficient Information

  MAUDE report 18377413 ↗
• 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 10/24/2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18368944 ↗
• 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 18182605 ↗
• MalfunctionOct 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 9/26/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-3632SP FIBERTAK SP AND AN AR-3652SP FIBERTAK RC ANCHORS PULLED OUT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17965851 ↗
• MalfunctionAug 31, 2023Break; Break

  ON 8/4/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL AN AR-3652SP FIBERTAK RC ANCHOR BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17663495 ↗
• MalfunctionAug 31, 2023Use of Device Problem; Use of Device Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3652SP FIBERTAK IMPLANT BACKED OUT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. NO DELAY, CASE COMPLETED USING SWIVELLOCK IN PLACE OF THE FIBERTAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662331 ↗
• MalfunctionJul 24, 2023Material Twisted/Bent; Material Twisted/Bent

  ON 6/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3652SP FIBERTAK RC ANCHOR TIP BEND UPON INSERTION. THE CASE WAS COMPLETED USING A SWIVELOCK. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023.

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

  MAUDE report 17378784 ↗
• MalfunctionJan 30, 2023Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE DEVICE COULD NOT BE INSERTED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. DUE TO THE DIFFERENT DEVICE THE SURGEON SWITCHED TO A DIFFERENT ANCHOR TECHNIQUE TO FINISH THE SURGERY SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16263287 ↗
• MalfunctionJul 11, 2022Device Slipped

  ON(B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3652SP FIBERTAK PULLED OUT OF IMPLANTATION SITE AND CREATED A BIGGER BONE SOCKET. SURGEON USED A 6.25 SWIVELOCK TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN RCR ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14976375 ↗