Arthrex® AR-3650DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867291799), received between Sep 10, 2024 and Jul 27, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Positioning Failure; Defective Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50006838 ↗
• MalfunctionMar 24, 2026Contamination

  ON 04-MAR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3650DS DISPOSABLES KIT FOR 2.6 FIBERTAK HAD A PIECE OF FOAM IN THE 2.6 FIBERTAK RC GUIDE. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. THE FOAM PIECE WAS REMOVED THE PATIENT. ADDITIONAL INFORMATION PROVIDED 13-MAR-2026: IT WAS FURTHER REPORTED THAT THE FOAM PIECE CAME OUT WHEN OBTURATOR WAS PLACED INTO THE GUIDE. THIS OCCURRED DURING A ROTATOR CUFF REPAIR PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674078 ↗
• MalfunctionFeb 26, 2025Material Fragmentation; Material Fragmentation

  ON 02/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3650DS DISPOSABLES KIT FOR 2.6 FIBERTAK ANCHORS AND (QTY. 3) OF AN AR-3632SP 2.6 FIBERTAK SP SOFT ANCHOR HAD AN ISSUE WHEN REPAIRING A SUPRASPINATUS TEAR. THE FIRST AR-3632SP 2.6 FIBERTAK SP SOFT ANCHOR WAS DEPLOYED SUCCESSFULLY, BUT THE DRILLING WAS PROBLEMATIC FOR THE FIRST ANCHOR. THE 2.6 DRILL WAS CONFIRMED TO BE APPROPRIATELY CHUCKED. THE SECOND SOCKET WAS MORE DIFFICULT, AND SOME METAL SHAVINGS WERE NOTICED AROUND THE DRILL SITE. THE SURGEON HAD TO REVERSE THE DRILL TO REMOVE IT FROM THE DRILL GUIDE, WHICH CAUGHT THE SUTURES FROM THE FIRST ANCHOR AND PULLED IT FROM THE SOCKET. THE SURGEON ASKED FOR TWO MORE AR-3632SP 2.6 FIBERTAK SP SOFT ANCHORS AND ATTEMPTED TO DEPLOY THEM IN EACH SOCKET, BUT BOTH PULLED OUT. THE SURGEON ABANDONED THE FIBERTAKS AND MOVED ON TO 5.5MM CORKSCREWS, WHICH WERE SUCCESSFULLY DEPLOYED IN THE PREVIOUSLY DRILLED SOCKETS. ALL METAL SHAVINGS WERE REMOVED FROM THE SITE, AND THE MEDIAL ROW SUTURES WERE PASSED, TIED, AND BRIDGED TO TWO 5.5MM SWIVELOCKS AS PLANNED. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21467544 ↗
• MalfunctionSep 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-2600FSB-1 FIBERTAK SPEED BRIDGE IMPLANT SYSTEM, WHILE USING THE AR-3650DS DISPOSABLES KIT FOR 2.6 FIBERTAK, HAD AN ISSUE WITH TWO OUT OF THE THREE 2.6 FIBERTAK RC SELF-PUNCHING SOFT ANCHORS RIPPING AND PULLING OUT AND NEVER FULLY SETTING UPON IMPLANTING. THE CASE WAS COMPLETED USING A 4.75 SWIVELOCK. THERE WAS UNDER 15 MINUTES OF DELAY IN REMOVING THE TWO SUTURE ANCHORS THAT HAD RIPPED. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181196 ↗