COBRA 3910900093Recalls & reported problems
Stryker Corporation · COBRA SUTURE PASSER, CAPTURE · Class 1
All models of COBRA (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker Cobra suture passer has 138 adverse event reports, with no deaths and 2 injuries. Many describe the needle bending, breaking or detaching during shoulder procedures, and the broken pieces were often retrieved. No recalls name 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
- 138
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 07613327413595), received between Jul 22, 2019 and Feb 24, 2026 — classified as 2 injuries, 136 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (68 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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent68
- Material Deformation41
- Break17
- Fracture17
- Material Integrity Problem4
- Mechanical Jam4
- Material Fragmentation3
- Failure to Advance2
Patient problems
- No Clinical Signs, Symptoms or Conditions136
- Insufficient Information4
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 138 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026Fracture
IT WAS REPORTED THAT WHILE TRYING TO PASS THE SUTURE THE NEEDLE BROKE WHERE IT CONNECTS TO THE PUSHING SHAFT. THE NEEDLE FELL ON THE FLOOR WHEN THE COBRA WAS PULLED OUT OF THE SHOULDER. THE CASE WAS COMPLETED BY USING A DIFFERENT PASSER. THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24435098 ↗MalfunctionFeb 6, 2026Fracture
IT WAS REPORTED THAT THE NEEDLE BROKE. ALL PIECES WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24283397 ↗MalfunctionJan 9, 2026Fracture
IT WAS REPORTED THAT THERE WAS BENT NEEDLE DEPLOYMENT/RETRACTION. BASED ON INVESTIGATION FINDINGS THERE WAS A BROKEN NEEDLE. PER ADDITIONAL INFORMATION RECEIVED, ALL PIECES WERE REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24020960 ↗MalfunctionJan 7, 2026Fracture
IT WAS REPORTED THAT THE NEEDLE BROKE DURING THE CASE. ALL PIECES WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23991084 ↗MalfunctionDec 17, 2025Fracture; Fracture
IT WAS REPORTED THAT THE NEEDLE HAD COMPLETELY DETACHED. THE DETACHED NEEDLE WAS IDENTIFIED AND FULLY REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23832428 ↗MalfunctionDec 16, 2025Fracture; Fracture
IT WAS REPORTED THAT THE NEEDLE BROKE WHILE PASSING THE SUTURE. THE END OF NEEDLE WAS RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822539 ↗MalfunctionDec 11, 2025Fracture; Fracture
IT WAS REPORTED THAT THERE WAS A BROKEN NEEDLE DURING PROCEDURE. ALL PIECES WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23780964 ↗MalfunctionNov 26, 2025Fracture; Fracture
IT WAS REPORTED THAT THE COBRA NEEDLE BROKE AND THAT ALL THE PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23659839 ↗MalfunctionOct 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A BROKEN NEEDLE OCCURRED DURING A CASE. ALL BROKEN PIECES WERE REMOVED, AND THE CASE WAS COMPLETED SUCCESSFULLY. NO ADVERSE EFFECTS TO PATIENT. THERE WAS A 10 MINUTE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23373956 ↗MalfunctionJul 15, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE NEEDLE TIP BROKE WHICH DELAYED THE CASE 20-30 MINUTES. X-RAY WAS BROUGHT IN TO FIND THE BROKEN TIP. THERE WEAS NO MEDICAL INTERVENTION OR ADVERSE EFFECTS TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22515954 ↗MalfunctionApr 7, 2025Fracture; Fracture
IT WAS REPORTED THAT THE NEEDLE OF THE PRODUCT BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21786818 ↗MalfunctionJul 23, 2024Fracture; Fracture
IT WAS REPORTED THAT THE NEEDLE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19812578 ↗MalfunctionJul 12, 2024Fracture; Fracture
IT WAS REPORTED THAT THE NEEDLE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19731843 ↗MalfunctionMay 24, 2024Fracture; Fracture
IT WAS REPORTED THAT THE NEEDLE BREAKING DURING THE PROCEDURE. THE BROKEN NEEDLE PIECE WAS NOT LEFT IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19397811 ↗MalfunctionMay 23, 2024Fracture; Fracture
IT WAS REPORTED THAT THE NEEDLE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19388400 ↗MalfunctionMar 1, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE NEEDLE BECAME BENT WHILE THE DEVICE WAS IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18820163 ↗MalfunctionMar 1, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE NEEDLE BECAME BENT WHILE THE DEVICE WAS IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18820146 ↗MalfunctionMar 1, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE NEEDLE BECAME BENT WHILE THE DEVICE WAS IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18816921 ↗MalfunctionMar 1, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE NEEDLE BECAME BENT WHILE THE DEVICE WAS IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18816916 ↗MalfunctionMar 1, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE NEEDLE BECAME BENT WHILE THE DEVICE WAS IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18816910 ↗MalfunctionFeb 5, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE NEEDLE BECAME BENT WHILE THE DEVICE WAS IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18646554 ↗MalfunctionJan 31, 2024Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent
IT WAS REPORTED THAT THE NEEDLE BECAME BENT WHILE THE DEVICE WAS IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18616525 ↗MalfunctionJan 25, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE NEEDLE BECAME BENT WHILE THE DEVICE WAS IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18582054 ↗MalfunctionJan 25, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE NEEDLE BECAME BENT WHILE THE DEVICE WAS IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18581880 ↗MalfunctionJan 19, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE NEEDLE BECAME BENT WHILE THE DEVICE WAS IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18547270 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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