NA 03.617.990Recalls & reported problems
Synthes GmbH · 2.0MM AWL WITH SLEEVE · 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 10705034717395), received between Sep 5, 2019 and Sep 5, 2019 — 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
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2019Break; Break
09/09/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED ON (B)(6) 2019, DURING 9 CERVICAL DISC OPERATION, THE AWL INSTRUMENT BROKE. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE WITHOUT ANY ADDITIONAL DELAY NOR PATIENT HARM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 2.0MM AWL WITH SLEEVE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8964222 ↗
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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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