NA 03.632.316Recalls & reported problems
Synthes GmbH · NAVIGABLE HANDLE FOR USE WITH ACCESS CANNULA · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034719764), received between Apr 19, 2017 and Apr 19, 2017 — classified as 1 malfunction.
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
- Material Fragmentation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 19, 2017Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) AND POSTERIOR SPINAL FUSION PROCEDURE ON (B)(6) 2017 FROM L4 TO S1, A SMALL PIECE OF THE QUICK COUPLING ATTACHMENT SHEARED OFF DURING IMPACTION. THERE WAS A 10 MINUTE DELAY; THE SURGERY WAS COMPLETED WITH NO REPORTED HARM TO THE PATIENT. THERE WERE NO REPORTED FRAGMENTS IN THE PATIENT. THIS REPORT IS FOR ONE (1) NAVIGABLE HANDLE THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6505488 ↗
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- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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