Iconix 3911-714-520Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840277402172), received between Oct 13, 2023 and Dec 6, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 25, 2023Class IIOpen, Classified

   Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill hole location leading to damage of the suture construct during insertion. Suture damage may lead to suture breaks during use.

   Z-0518-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2024Fracture; Fracture

  ACCORDING TO THE REPORTER: "PIECE OF INSERTER FOUND IN BONE. PIECE WAS REMOVED FROM BONE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20869198 ↗
• MalfunctionMar 11, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, "ANCHORS PULLED OUT AND DID NOT OPERATE PROPERLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18879500 ↗
• MalfunctionNov 3, 2023Material Twisted/Bent; Material Twisted/Bent

  ACCORDING TO THE REPORTER, "KNOTLESS ICONIX BENT. ANCHORS BENT WHILE INSERTING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067609 ↗
• MalfunctionOct 27, 2023Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, "(1.8MM STRYKER TRAUMA DRILL 4933-8-010) *DRILL USED AT SURGEONS REQUEST AND DISCRETION. IMPLANT INSERTED. IMPLANT PULLED OUT WHEN SURGEON ATTEMPTED TO SET ANCHOR. SURGEON BELIEVES HE CONVERGED TUNNELS WHICH LED TO PULL OUT. A 2.6MM ARTHREX FIBERTAK KNOTLESS WAS USED IN DRILL HOLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18025002 ↗
• MalfunctionOct 25, 2023Fracture; Fracture

  ACCORDING TO THE REPORTER, "DR. (B)(6) UTILIZED THE REUSABLE ICONIX 1.4MM DRILL AND CYCLED IT A FEW TIMES TO MAKE A PILOT HOLE FOR THE ICONIX KNOTLESS IMPLANT (PN 3911714520). THE IMPLANT FAILED TO INSERT INTO THE HOLE. THE INSERTER BUCKLED DURING THE INSERTION ATTEMPT, BENDING THE GUIDE NEAR ITS DISTAL TIP. THE TIP OF THE INSERTER BROKE DURING THE INSERTION ATTEMPT AND WAS SUBSEQUENTLY RETRIEVED AND REMOVED FROM THE PATIENT. THE SHUTTLE SUTURE FRAYED WHEN PASSED WITH THE NANOPASS. NONE OF THE IMPLANT, NOR ITS INSERTER WAS LEFT IN THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007149 ↗
• InjuryOct 20, 2023Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  ACCORDING TO THE REPORTER, "(1.6MM ARTHREX DRILL FROM DISPOSABLE KIT AR-3600DC) IMPLANT INSERTED. DURING THE SHUTTLING STEP THE SHUTTLE GOT "STUCK" RIGHT WERE THE BEGINNING OF THE TUCKED SHUTTLE LOOP IS ENTERING THE FINGERTRAP MECHANISM IN THE ICONIX KNOTLESS IMPLANT. THE SURGEON REPEATEDLY TRIED TO FINISH THE SHUTTLING, BUT EVENTUALLY BROKE THE SHUTTLE TAIL IN THIS ATTEMPT. THE REMAINING STRANDS WERE CUT AND THE ANCHOR REMAINED IN THE PATIENT. AFTER THE SURGERY IT WAS NOTICED THAT THE INSERTER FOR ICONIX KNOTLESS INSERTER #2 WAS MISSING ONE OF THE 2 FORK TIPS. THE SURGEON WAS NOTIFIED. THERE IS A POTENTIAL THAT THE INSERTER FORK TIP WAS IMPLANTED INTO THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 17980969 ↗
• MalfunctionOct 18, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ACCORDING TO THE REPORTER, "1 IMPLANT HAD THE FOLLOWING EXPERIENCE DURING HIP LABRAL REPAIR, 27 YEAR OLD FEMALE, ANTERIOR ACETABULUM LOCATION: PILOT HOLE MADE WITH 1.5MM STEINMANN PIN WHICH DID NOT PLUNGE DURING THE DRILLING PROCESS. IMPLANT SUCCESSFULLY INSERTED. IMPLANT PULLED OUT DURING THE DEPLOYMENT/SETTING OF THE ANCHOR IN THE BONE.NO PORTION OF THE IMPLANT REMAINED IN THE BONE/PATIENT. THE SURGEON SUBSEQUENTLY SUCCESSFULLY INSERTED A CINCHLOCK SS IMPLANT "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962307 ↗
• MalfunctionOct 13, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ACCORDING TO THE REPORTER, "PILOT HOLE MADE WITH 1.8MM STEINMANN PIN. IMPLANT SUCCESSFULLY INSERTED BUT UPON ATTEMPTED SET/DEPLOYMENT OF THE ANCHOR, IT PULLED OUT. NO PORTION OF THE IMPLANT REMAINED IN THE PATIENT. SUBSEQUENTLY, A CINCH LOCK SS (B)(6) ANCHOR WAS ABLE TO BE UTILIZED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17935693 ↗
• MalfunctionOct 13, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ACCORDING TO THE REPORTER, "PILOT HOLE MADE WITH 1.5MM STEINMANN PIN. IMPLANT WAS UNABLE TO BE INSERTED. THE INSERTER BUCKLED. NO PORTION OF THE IMPLANT REMAINED IN THE PATIENT. EVENTUALLY (AFTER IMPLANT EVENT #3), A CINCHLOCK SS (CAT02462) ANCHOR WAS ABLE TO BE UTILIZED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17935670 ↗
• MalfunctionOct 13, 2023Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, "PILOT HOLE MADE WITH 1.5MM STEINMANN PIN. IMPLANT SUCCESSFULLY INSERTED. SHUTTLE STRAND BROKE UPON DIFFICULTY GETTING THE BEGINNING OF THE LOOP PORTION TO ENTER INTO THE FINGERTRAP. THE REMAINING SHUTTLE STRAND WAS ABLE TO BE REMOVED FROM THE PATIENT. AS THE REPAIR TAIL WAS PULLED TO ALSO REMOVE IT FROM THE PATIENT THE IMPLANT WAS ABLE TO GET PULLED OUT OF THE PATIENT SUCH THAT NO PORTION OF THE IMPLANT REMAINED IN THE PATIENT. EVENTUALLY (AFTER IMPLANT EVENT #3), A CINCHLOCK SS (B)(6) ANCHOR WAS ABLE TO BE UTILIZED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17935665 ↗
• MalfunctionOct 13, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ACCORDING TO THE REPORTER, "3 ICONIX KNOTLESS IMPLANTS WERE SUCCESSFULLY UTILIZED FOR A SHOULDER INSTABILITY REVISION PROCEDURE. 1 MORE IMPLANT HAD THE FOLLOWING EXPERIENCE: THE REPAIR TAIL BROKE DURING TENSIONING. A REVIEW OF THE SURGICAL VIDEO INDICATES THAT THE REPAIR TAIL WAS INADVERTENTLY PASSED THROUGH ITSELF DURING THE SURGICAL PROCEDURE CREATING A SITUATION WHERE IT WOULD BE UNABLE TO PASS THROUGH THE FINGERTRAP MECHANISM AND SUBSEQUENTLY BREAK. THE REMAINING REPAIR TAIL WAS REMOVED FROM THE PATIENT WHILE THE ALL SUTURE IMPLANT BODY STAYED IN THE PATIENT'S GLENOID BONE. THE SURGEON MOVED TO A NEW DRILLING LOCATION AND SUCCESSFULLY INSERTED ANOTHER ICONIX KNOTLESS IMPLANT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17935628 ↗