N/A 9339082Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INSTRUMENT 9339082 MOD QC RATCHET HNDL · Class 1
Data updated Oct 16, 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 00721902837999), received between Dec 7, 2020 and Dec 7, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION AND SPINAL INSTRUMENTS BEING USED INTRA-OPERATIVELY OF A SPINAL L4/5 STENOSIS PROCEDURE. IT WAS REPORTED THAT THE LEGACY RATCHET AND PROVISIONAL BREAK OFF. THE RATCHET HANDLE BROKE. THEY DID NOT BREAK INSIDE THE PATIENT ANATOMY. THERE WAS NO IMPACT ON THE PATIENT INCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT ALL THREE INSTRUMENTS WERE ALL BROKEN. THE PROVISIONAL WOULD NO LONGER RETAIN THE BREAK OFF SCREWS. THE RATCHET HANDLES WERE NO LONGER WORKING. THE CAPS ON TOP FELL OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10960913 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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