ICONIX 3910-500-512Recalls & reported problems
Stryker Corporation · 1.4MM ICONIX 1 ANCHOR W/INTELLIBRAID TECHNOLOGY 1 STRAND #2 FORCE FIBER · Class 2 · Implant
All models of ICONIX (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker ICONIX soft tissue anchor is a small suture anchor used to fasten tissue to bone. The 30 reports mostly describe the anchor or its inserter tip breaking during placement, sometimes leaving a fragment or wire inside the patient, along with a few reports of expired product being used. Reports mention 15 injuries and no deaths, with 15 malfunctions. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 07613252450337), received between Feb 18, 2019 and Aug 27, 2026 — classified as 15 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Break” (14 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.
Reports received per month
Most reported problems
Device problems
- Break14
- Fracture5
- Adverse Event Without Identified Device or Use Problem3
- Expiration Date Error3
- Nonstandard Device3
- Patient Device Interaction Problem3
- Contamination /Decontamination Problem1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Foreign Body In Patient9
- Insufficient Information3
- No Known Impact Or Consequence To Patient3
- Scar Tissue3
- Synovitis3
- Hypersensitivity/Allergic reaction2
- Reaction to Medicinal Component of Device1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Fracture
It was reported that the broken tip portion of the ICONIX remained in the patient's glenoid cavity.
Patient problems: Foreign Body In Patient
MAUDE report 50488472 ↗MalfunctionSep 24, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE OFF, LEAVING FRAGMENTS IN THE PATIENT'S BONE.
Patient problems: Foreign Body In Patient
MAUDE report 23139111 ↗InjuryApr 29, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT HOLDING THE ANCHOR BROKE OFF DURING IMPLANT INSERTION. THE TIP OF THE ICONIX REMAINED IN THE PATIENT BONE.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 21931158 ↗InjuryJun 8, 2024Fracture; Fracture
IT WAS REPORTED THAT AFTER INSERTING THE ANCHOR INTO THE BONE, THE TIP PART OF THE INSERTER WAS BROKEN AND WAS LEFT IN THE PATIENT'S BODY WITH THE ANCHOR.
Patient problems: Foreign Body In Patient
MAUDE report 19493688 ↗MalfunctionMay 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE THE ANCHOR UNIT WAS USED AND FAILED IN PERFORMANCE. THE WIRE REMAINED IN THE PATIENT AND IT WAS NOT POSSIBLE TO REMOVE IT, THE ANCHOR WAS NEGLECTED, AND CAUSED NO HARM TO THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 19274360 ↗InjuryMay 7, 2024Fracture; Fracture
IT WAS REPORTED THAT THERE WAS TIP BREAKAGE OF THE DEVICE AND THE FRAGMENT REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 19265131 ↗MalfunctionNov 9, 2023Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18107019 ↗MalfunctionJul 12, 2023Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17312739 ↗MalfunctionMay 25, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THERE WAS THERE WAS INTENSE SYNOVITIS AND SCARRING AROUND THE ANCHOR PREVIOUSLY IMPLANTED. AN ADDITIONAL PROCEDURE WAS COMPLETED TO REMOVE.
Patient problems: Scar Tissue; Synovitis
MAUDE report 17007934 ↗InjuryMay 25, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THERE WAS THERE WAS INTENSE SYNOVITIS AND SCARRING AROUND THE ANCHOR PREVIOUSLY IMPLANTED. AN ADDITIONAL PROCEDURE WAS COMPLETED WHERE IMMEDIATE RELIEF WAS FELT UPON REMOVAL.
Patient problems: Scar Tissue; Synovitis
MAUDE report 17007933 ↗InjuryMay 25, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THERE WAS THERE WAS INTENSE SYNOVITIS AND SCARRING AROUND THE ANCHOR PREVIOUSLY IMPLANTED. AN ADDITIONAL PROCEDURE WAS COMPLETED TO REMOVE.
Patient problems: Scar Tissue; Synovitis
MAUDE report 17007060 ↗MalfunctionMar 15, 2023Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED DEVICE WAS USED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16549750 ↗MalfunctionMar 1, 2023Break
IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16463973 ↗MalfunctionDec 1, 2022Break
IT WAS REPORTED THAT THE INSERTER TIP BROKE OFF AND REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 15898727 ↗MalfunctionJan 19, 2022Break
IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE DURING THE PROCEDURE. THE BROKEN PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13292065 ↗MalfunctionNov 9, 2021Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO THE DEVICES. NOTE, THERE ARE NO PLANS TO PERFORM AN ADDITIONAL PROCEDURE.
Patient problems: Hypersensitivity/Allergic reaction; No Clinical Signs, Symptoms or Conditions
MAUDE report 12779202 ↗MalfunctionNov 9, 2021Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO THE DEVICES. NOTE, THERE ARE NO PLANS TO PERFORM AN ADDITIONAL PROCEDURE.
Patient problems: Hypersensitivity/Allergic reaction; No Clinical Signs, Symptoms or Conditions
MAUDE report 12779201 ↗MalfunctionNov 9, 2021Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO THE DEVICES. NOTE, THERE ARE NO PLANS TO PERFORM AN ADDITIONAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions; Reaction to Medicinal Component of Device
MAUDE report 12779198 ↗MalfunctionOct 11, 2021Break
IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12606264 ↗InjuryAug 2, 2021Break; Break
IT WAS REPORTED THAT METAL REMAINED IN THE JOINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12264169 ↗InjuryAug 2, 2021Break; Break
IT WAS REPORTED THAT METAL REMAINED IN THE JOINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12264167 ↗InjuryAug 2, 2021Break; Break
IT WAS REPORTED THAT METAL REMAINED IN THE JOINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12264154 ↗InjuryAug 2, 2021Break; Break
IT WAS REPORTED THAT METAL REMAINED IN THE JOINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12264098 ↗InjuryAug 2, 2021Break; Break
IT WAS REPORTED THAT METAL REMAINED IN THE JOINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12264076 ↗InjuryAug 2, 2021Break; Break
IT WAS REPORTED THAT METAL REMAINED IN THE JOINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12264075 ↗
Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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