ICONIX 3910-500-522Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613252450344), received between Sep 17, 2018 and Jun 12, 2026 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Material Fragmentation

  It was reported that after drill hole was prepared using a 2.3mm drill and the anchor was impacted into the bone, the inserter shaft was removed and found the tip was missing. The missing tip was about 1mm and could not be found on table. It was believed that the tip was left in the anchor, which was inside the patient's glenoid intrabony. The doctor thought that the metal piece was fixed inside bone and decided to continue the surgery without removing it.

  Patient problems: Foreign Body In Patient

  MAUDE report 25487285 ↗
• MalfunctionJan 16, 2026Material Fragmentation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING IMPLANT PLACEMENT, THE ANCHOR GOT LOOSE AND IT WAS NOT EMBEDDED IN THE BONE, ANOTHER IMPLANT WAS USED IN THE SAME CANAL. IMPLANT WAS RETRIEVED FROM PATIENT BODY. THERE WERE NO DEVICE FRAGMENTS LEFT IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24099195 ↗
• MalfunctionOct 28, 2025Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE DEVICE HAD A DATE OF EXPIRATION OF (B)(6) 2025 AND IT WAS IMPLANTED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408570 ↗
• InjuryAug 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING INSERTION OF THE ANCHOR, ONE OF THE PRONGS OF THE INSERTION DEVICE BROKE OFF WITHIN THE BONE. THE PIECE WAS POTENTIALLY LEFT IN PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20057891 ↗
• MalfunctionMar 14, 2023Break

  IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE DURING PROCEDURE. NO PIECES WERE FOUND IN PATIENT VIA XRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542051 ↗
• MalfunctionJan 18, 2023Break

  IT WAS REPORTED THE INSERTER BROKE DURING PROCEDURE AND PIECES WERE LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16199685 ↗
• MalfunctionDec 14, 2022Break

  IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982656 ↗
• MalfunctionJun 9, 2022Break; Difficult to Remove

  IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE DURING THE PROCEDURE AND REMAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14642634 ↗
• MalfunctionMar 10, 2022Break; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE AND POTENTIALLY REMAINS IN THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13724858 ↗
• InjuryOct 27, 2020Break; Break

  IT WAS REPORTED THAT THERE WAS A POTENTIAL OF THE INSERTER ON THE DEVICE BREAKING DURING THE PROCEDURE AND POTENTIALLY REMAINS IN THE JOINT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 10744485 ↗
• InjuryJul 28, 2020Appropriate Device Problem Term/Code Not Available; Separation Problem; Separation Problem

  IT WAS REPORTED THAT THERE WAS A NEED FOR A REVISION SURGERY.

  Patient problems: Implant Pain; No Known Impact Or Consequence To Patient

  MAUDE report 10336207 ↗
• MalfunctionNov 14, 2019Break

  IT WAS REPORTED THAT THE INSERTER BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9323352 ↗
• InjurySep 17, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED BECAUSE THE BONE AROUND THE IMPLANT HAD A HOLE ABOUT 1 CM OF DIAMETER.

  Patient problems: No Code Available

  MAUDE report 7881075 ↗