Arthrex® AR-3653TTSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867370081), received between Nov 21, 2023 and Jul 29, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Material Frayed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50069327 ↗
• MalfunctionFeb 16, 2026Use of Device Problem

  ON 28-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3653TTSP KNOTLESS 2.6 FIBERTAK RC SOFT ANCHOR ALLOWED THE FIBERTAPE TO SLIDE WITHIN THE KNOTLESS ANCHOR WHEN IT SHOULD HAVE REMAINED FIXED. THE ISSUE WAS IDENTIFIED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344305 ↗
• MalfunctionDec 1, 2025Positioning Failure; Positioning Failure

  ON 11/10/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3653TTSP KNOTLESS 2.6 FIBERTAK® RC SOFT ANCHORS REPAIR STITCH WOULD NOT SHUTTLE THROUGH. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2025. THE ANCHOR REMAINS IN THE PATIENT, AND THE SUTURE WAS CUT OUT. THERE WAS A DELAY OF ABOUT TEN MINUTES WHERE ADDITIONAL ANESTHESIA WAS NOT ADMINISTERED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23682578 ↗
• MalfunctionMay 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 04/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3653TTSP KNOTLESS 2.6 FIBERTAK® RC SOFT ANCHORS REPAIR STITCH PULLED OUT. THIS OCCURRED DURING A ROTATOR CUFF REPAIR WHERE THE ANCHOR REMAINED HOWEVER THE STITCH COULDN'T BE UTILIZED.

  Patient problems: Insufficient Information

  MAUDE report 21959489 ↗
• MalfunctionMay 6, 2024Use of Device Problem; Use of Device Problem

  ON 2/1/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3653TTSP KNOTLESS FIBERTAK DR WOULD NOT SET, EVEN AFTER MULTIPLE ATTEMPTS FROM THE SURGEON TO DEPLOYED THE ANCHOR. THIS WAS DISCOVERED DURING A RCR PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 2/2/2022: THE CASE WAS COMPLETED BY THE DOCTOR USING (2) 2324KBCCT 4.75 SWIVELOCK ANCHORS. NOTHING BROKE INSIDE THE PATIENT AND CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247077 ↗
• MalfunctionMar 18, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 02/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3653TTSP KNOTLESS FIBERTAK SELF PUNCHING TECHNOLOGY FAILED, THE INSERTER BENT AND FRAYED THE SUTURES RUINING THE IMPLANT. CASE COMPLETED USING A DRILL HOLE AND ANOTHER FIBERTAK. DELAY IN CASE 4 MINUTES. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18922892 ↗
• MalfunctionFeb 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-3653TTSP KNOTLESS 2.6 FIBERTAK® RC SOFT ANCHOR PULLED OUT. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2024, WHERE A 2.6 KNOTLESS FIBERTAK RC WAS PREPPED USING A 2.6 DRILL AND 2.6 DRILL GUIDE FOR A MEDIAL ROW ANCHOR PLACEMENT ON THE GREATER TUBEROSITY. THE ANCHOR WAS INSERTED IN STANDARD FASHION, SET IN STANDARD FASHION, AND THEN THE TAPES FROM THE ANCHOR WERE PASSED THROUGH THE ROTATOR CUFF. WHEN ATTEMPTING TO IMPLANT THE LATERAL ROW ANCHOR WITH THE TAPES FROM THE 2.6 MEDIAL ANCHOR, THE 2.6 KNOTLESS RC PULLED OUT. THE CASE WAS COMPLETED WITH NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18678230 ↗
• MalfunctionJan 29, 2024Component Missing; Component Missing

  ON 01/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3653TTSP KNOTLESS FIBERTAK DID NOT HAVE THE SHUTTLE SUTURE ATTACHED TO IT. THE SURGEON COMPLETED THE REPAIR USING A 5.5 CORKSCREW. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595309 ↗
• MalfunctionDec 6, 2023Break; Break

  ON 11/9/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3653TTSP KNOTLESS 2.6 FIBERTAK RC SUTURES WERE FRAYED. WHEN THE SURGEON PULLED ON THE SUTURES, THE REPAIR STITCH FELL OUT. THE CASE WAS COMPLETED WITHOUT THE MEDIAL MATTRESS CONFIGURATION. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18278398 ↗
• MalfunctionNov 21, 2023Failure to Advance; Failure to Advance

  ON 10/24/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3653TTSP KNOTLESS 2.6 FIBERTAK SUTURE WOULD NOT DEPLOY. THIS OCCURRED DURING A BANKART PROCEDURE ON 10/24/2023. THE CASE WAS COMPLETED USING ANOTHER AR-3653TTSP THAT WORKED ACCORDINGLY. AN EXTRA HOLE NEEDED TO BE DRILLED THAT WAS NOT INITIALLY PLANNED FOR.

  Patient problems: Insufficient Information

  MAUDE report 18182541 ↗