Arthrex® AR-3653SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867370043), received between Oct 9, 2023 and Jan 5, 2026 — classified as 8 malfunctions.

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

• MalfunctionJan 5, 2026Device Dislodged or Dislocated

  ON 16-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3653TSP KNOTLESS 2.6 FIBERTAK RC SOFT ANCHOR AND TWO AR-3653SP KNOTLESS 2.6 FIBERTAK RC SOFT ANCHORS FAILED TO DEPLOY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/24/2025: DURING A ROTATOR CUFF REPAIR PROCEDURE, ONE AR-3653TSP KNOTLESS 2.6 FIBERTAK RC SOFT ANCHOR AND TWO AR-3653SP KNOTLESS 2.6 FIBERTAK RC SOFT ANCHORS PULLED OUT OF THE BONE BUT REMAINED INTACT, WITH NO FRAGMENTS LEFT BEHIND. THE PROCEDURE WAS COMPLETED USING AR-2324BCC BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR AND AR-2323BCC BIOCOMPOSITE SWIVELOCK SUTURE ANCHOR. THE EVENT RESULTED IN A 10¿15-MINUTE DELAY, REQUIRING ADDITIONAL ANESTHESIA FOR THE SAME DURATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23959460 ↗
• MalfunctionJan 5, 2026Device Dislodged or Dislocated

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3653TSP KNOTLESS 2.6 FIBERTAK RC SOFT ANCHOR AND TWO AR-3653SP KNOTLESS 2.6 FIBERTAK RC SOFT ANCHORS FAILED TO DEPLOY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/24/2025: DURING A ROTATOR CUFF REPAIR PROCEDURE, ONE AR-3653TSP KNOTLESS 2.6 FIBERTAK RC SOFT ANCHOR AND TWO AR-3653SP KNOTLESS 2.6 FIBERTAK RC SOFT ANCHORS PULLED OUT OF THE BONE BUT REMAINED INTACT, WITH NO FRAGMENTS LEFT BEHIND. THE PROCEDURE WAS COMPLETED USING AR-2324BCC BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR AND AR-2323BCC BIOCOMPOSITE SWIVELOCK SUTURE ANCHOR. THE EVENT RESULTED IN A 10¿15-MINUTE DELAY, REQUIRING ADDITIONAL ANESTHESIA FOR THE SAME DURATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23958720 ↗
• 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. (B)(4), 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 23719748 ↗
• MalfunctionFeb 7, 2025Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3653SP KNOTLESS 2.6 FIBERTAK RC SOFT ANCHOR HAD AN ISSUE. DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, WHEN THE SURGEON WAS WORKING THROUGH THE POSTERIOR CANNULA AND HAD INSERTED THE ANCHOR, IT DID NOT SEAT PROPERLY. WHEN PULLING ON THE SUTURES, THE ANCHOR CAME OUT OF THE PATIENT'S BODY IN ONE PIECE. NOTHING BROKE INSIDE THE PATIENT, AND EVERYTHING WAS REMOVED FROM THE PATIENT. ANOTHER AR-3653SP KNOTLESS 2.6 FIBERTAK RC SOFT ANCHOR WITH A DIFFERENT UNKNOWN LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO HARM TO THE PATIENT. THE COMPLAINT DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN. THERE WAS A CASE DELAY OF A COUPLE OF MINUTES, AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334380 ↗
• MalfunctionFeb 23, 2024Defective Device; Defective Device

  ON 2/1/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3653SP KNOTLESS 2.6 FIBERTAK RC MATTRESS STITCH WOULDN'T TENSION DOWN. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED BY REVERTING TO ANOTHER ANCHOR AND TYING THE KNOTS. THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767746 ↗
• MalfunctionDec 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3653SP KNOTLESS 2.6 FIBERTAK RC FIBERLINK SUTURE TORE DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING ANOTHER AR-3653SP KNOTLESS 2.6 FIBERTAK RC. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THIS WAS DISCOVERED DURING AN RCR PROCEDURE. BEFORE USING THE NEW R-3653SP KNOTLESS 2.6 FIBERTAK RC TO COMPLETE THE CASE, ALL THE FRAGMENTS FROM THE PREVIOUS FIBERTAK WERE REMOVED. THE CASE WAS DELAYED A FEW SECONDS, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378193 ↗
• MalfunctionOct 16, 2023Material Twisted/Bent; Material Twisted/Bent

  ON 9/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-3600 FIBERTAK ANCHORS PULLED OUT. THE SUTURES WERE NOT BALLING UP AND APPEARED STRAIGHT. THE SURGEON ATTEMPTED TO USE AN AR-3653SP KNOTLESS FIBERTAK, AND THE SHAFT BENT DURING INSERTION; DID NOT BREAK. THE CASE WAS COMPLETED USING A COMBINATION OF AR-3600 FIBERTAK AND PRODUCTS FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING A GLENOID FRACTURE PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17941097 ↗
• MalfunctionOct 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3653SP SUTURE ANCHOR SHUTTLE SUTURE WOULD NOT SLIDE, ANCHOR BACKED OUT DUE TO THE PRESSURE OF TRYING TO GET THE SUTURE TO SLIDE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. CASE COMPLETED WITH ANOTHER ANCHOR AND NEW HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894262 ↗