NA 03.632.220Recalls & reported problems
Synthes GmbH · NAVIGABLE AWL-TAP 3.5MM DUAL CORE/6MM HXC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034719542), received between Sep 18, 2018 and Sep 18, 2018 — classified as 1 injury.
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.
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2018Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2018, PATIENT UNDERWENT A SPINAL FUSION PROCEDURE. DURING THE SURGERY, A NAVIGABLE AWL-TAP BROKE OFF. SURGEON WAS UNABLE TO EXTRACT TAP FROM THE PATIENT PEDICLE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE NOT REPORTED. THIS REPORT IS FOR ONE (1) NAVIGABLE AWL-TAP 3.5MM DUAL CORE/6MM HXC. THIS IS REPORT 1 OF 6 FOR (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 7886702 ↗
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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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