NA 3910-100-035Recalls & reported problems
Stryker Corporation · 5MM CUFF ANCHOR WITH 2 STRANDS #2 FORCE FIBER, 2 CHANNELS · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613154015306), received between Jul 5, 2018 and Sep 21, 2026 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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
- Delivered as Unsterile Product3
- Expiration Date Error2
- Adverse Event Without Identified Device or Use Problem1
- Device Contaminated During Manufacture or Shipping1
- Device Markings/Labelling Problem1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848337 ↗MalfunctionMar 6, 2026Expiration Date Error
IT WAS REPORTED THAT THE ITEM WAS IMPLANTED AFTER IT WAS EXPIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24533797 ↗MalfunctionJun 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE ANCHOR APPEARS TO BE UNSEALED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22331967 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE 5.0 MM WEDGE TITANIUM ANCHOR WAS NOT PROPERLY SEALED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22290126 ↗MalfunctionMar 11, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THERE WAS A BREACH IN THE STERILE BARRIER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18881437 ↗MalfunctionMay 5, 2022Mechanical Problem; Mechanical Problem
IT WAS FOUND THAT A PIECE WAS BROKEN AND MISSING FROM THE DEVICE. IT WAS UNABLE TO BE DETERMINED IF THIS OCCURRED DURING A PROCEDURE, HOWEVER UPON INTAKE IT WAS INDICATED THAT NO PIECES WERE LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14294704 ↗MalfunctionFeb 27, 2020Expiration Date Error; Device Markings/Labelling Problem; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9766196 ↗InjuryJul 5, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT NEEDED REVISION SURGERY. HOWEVER, PLEASE NOTE THAT THE METAL IN THIS DEVICE IS HIGHLY UNLIKELY TO CAUSE THE ALLEGED REACTION.
Patient problems: No Code Available
MAUDE report 7665394 ↗
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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