ICONIX 3910500222Recalls & reported problems
Stryker Corporation · ICONIX 2 NEEDLES WITH INTELLIBRAID TECHNOLOGY, 2.3MM ANCHOR WITH 2.0MM XBRAID TT · Class 2 · Implant
All models of ICONIX (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327283464), received between Mar 16, 2021 and Jan 16, 2026 — classified as 3 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Material Separation3
- Difficult to Remove1
- Fracture1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Foreign Body In Patient3
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2026Fracture
IT WAS REPORTED THAT AFTER INSERTING THE ANCHOR AND REMOVING THE INSERTER, ONE PRONG OF THE DISTAL FORK WAS FOUND TO BE FRACTURED. IT WAS LATER CONFIRMED THAT THE FRACTURED PRONG REMAINED INSIDE THE BONE ALONG WITH THE ANCHOR.
Patient problems: Foreign Body In Patient
MAUDE report 24099946 ↗MalfunctionMar 27, 2023Material Separation; Material Separation
IT WAS REPORTED THAT THE NEEDLE SEPARATED DURING PROCEDURE. THE NEEDLE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16618149 ↗MalfunctionJan 18, 2023Material Separation; Separation Problem; Material Separation
IT WAS REPORTED THAT THE NEEDLE SEPARATED DURING PROCEDURE. THE NEEDLE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16200008 ↗InjuryJan 18, 2023Difficult to Remove; Material Separation
IT WAS REPORTED THAT THE NEEDLE SEPARATED DURING PROCEDURE AND WAS POTENTIALLY UNABLE TO BE RETRIEVED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 16200007 ↗InjuryApr 13, 2022Break
IT WAS REPORTED THAT THE INSERTER BROKE AND REMAINED IN THE PATIENT'S BONE.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 14103058 ↗MalfunctionJan 24, 2022Break
IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE DURING THE PROCEDURE AND REMAINS IMBEDDED IN THE BONE.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 13334975 ↗MalfunctionMar 16, 2021Break; Break
IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11496033 ↗
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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