NA 3010-19-016Recalls & reported problems
Medos International Sàrl · NAVIGATION ENABLED INSTRUMENTS DUAL LEAD CANNULATED TAP 6MM · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034561486), received between Mar 2, 2023 and Nov 12, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Material Deformation1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2025Material Deformation; Material Deformation
IT WAS REPORTED ON OCT 24, 2025, THAT NAVIGATION TAP WAS BENT. IT IS UNKNOWN IF THE PATIENT EXPERIENCED AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. IT IS ALSO NOT KNOWN IF THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL.
Patient problems: Insufficient Information
MAUDE report 23535131 ↗MalfunctionMar 2, 2023Break; Break
IT WAS REPORTED THAT ON 2/12/2023, DURING AN UNKNOWN PROCEDURE T20 NAV-LOCK DRIVER TIP BROKE AND 6MM CANNULATED NAV-LOCK TAP BROKE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 6MM NAV DUAL LEAD CAN TAP. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16472825 ↗
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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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