Iconix 3911-714-522Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00840277404756), received between Apr 1, 2025 and Mar 18, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Material Integrity Problem

  ACCORDING TO THE REPORTER, "SURGEON WAS USING MALLET TO INSERT ICONIX KNOTLESS 1.4MM INTO THE ACETABULUM, ON INSERTION OF THE ANCHOR THE TIP OF THE INSERTED SHEATH SNAPPED OFF AND STAYED IN THE ACETABULUM, DUE TO THE NATURE OF WHERE IT WAS THE SURGEON DECIDED AGAINST REMOVING IT, ANOTHER ANCHOR WAS USED IN A DIFFERENT LOCATION WITH NIL ISSUES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630015 ↗
• MalfunctionJan 29, 2026Patient Device Interaction Problem

  ACCORDING TO THE REPORTER:"DR. (B)(6) HAD EXPERIENCED SOFT BONE SETTINGS WHERE IMPLANTS DID NOT SET. SALESFORCE CASE NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24215447 ↗
• MalfunctionJan 6, 2026Patient Device Interaction Problem

  ACCORDING TO THE REPORTER:"THE ITEMS WERE WASTED BECAUSE THE IMPLANTS PULLED OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981830 ↗
• MalfunctionJan 5, 2026Material Twisted/Bent

  ACCORDING TO THE REPORTER: "THE ANCHOR BENT ON INSERTION & PULLED OUT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958784 ↗
• MalfunctionDec 30, 2025Fracture; Fracture

  ACCORDING TO THE REPORTER: "THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS PATIENT CAME BACK IN FOR POST-OP X-RAYS AND THERE WAS A SMALL PIECE OF METAL THAT WAS DISCOVERED IN THEIR SHOULDER. THE PATIENT AND DR. HATZIDAKIS DECIDED TO SCHEDULE THE PATIENT FOR A SURGERY ON (B)(6) 2025. DURING THAT SURGERY ON (B)(6) 2025 IT WAS DISCOVERED THAT THIS PIECE OF METAL WAS A PART OF THE 1.4MM ICONIX KNOTLESS INSERTER. DR. HATZIDAKIS WAS ABLE TO SUCCESSFULLY REMOVE THIS PIECE OF THE 1.4MM ICONIX KNOTLESS INSERTER FROM THE PATIENTS SHOULDER DURING THAT SURGERY.."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924111 ↗
• MalfunctionDec 22, 2025Fracture; Fracture

  ACCORDING TO THE REPORTER: "WE WERE INFORMED BY A SURGEON TODAY THAT UPON DOING POST-OP X-RAYS IN HIS OFFICE, HE DISCOVERED A SMALL PIECE OF WHAT HE BELIEVED TO BE OF A STRYKER KNOTLESS ANCHOR THAT WAS IN THE SHOULDER. HE STATED THIS WAS HIS FIRST TIME USING THE STRYKER KNOTLESS. WE HAVE ALREADY CONTACTED OUR LOCAL STRYKER SALE REP AND LET THEM KNOW OF THE ISSUE. HE DID NOT REPORT KNOWING OF ANY OTHER ISSUES WITH THIS ANCHOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866171 ↗
• MalfunctionDec 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER: "ICONIX KNOTLESS ANCHOR IMPLANTED. SLIDING MECHANISM OF THE ANCHOR FAILED AND WAS STUCK. HAD TO TIE DOWN KNOTS LIKE A KNOTTED ANCHOR INSTEAD OF SLIDING INTO A KNOTLESS ANCHOR. NOTICED AFTER IMPLANTATION, WHEN TRYING TO PASS REPAIR STRAND."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823791 ↗
• MalfunctionOct 22, 2025Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, "ANCHOR PULLED OUT, SOFT BONE, TOUGH ANGLE. ITEM WASTED ON BILL ONLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360982 ↗
• MalfunctionOct 22, 2025Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, "YES, THIS ANCHOR DID NOT PERFORM AS INTENDED. IT PULLED OUT OF THE BONE WITHOUT DEPLOYING. SO, IT DID NOT GET IMPLANTED INTO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359265 ↗
• MalfunctionOct 22, 2025Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, "ANCHOR FAILED. CUSTOMER WAS UNHAPPY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358385 ↗
• MalfunctionMay 2, 2025Fracture; Fracture

  ACCORDING TO THE REPORTER: "ICONIX INSERTER BROKE OFF IN BONE WHEN PLACING ANCHOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952116 ↗
• MalfunctionApr 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER: "AFTER CUTTING REPAIR STRANDS. ANCHOR LOOSENED AND THEN SUTURES WERE CUT OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21747195 ↗