NA 03.010.039Recalls & reported problems
Synthes GmbH · 10.0MM CANNULATED AWL · Class 1
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 10886982067128), received between Jul 8, 2022 and Jul 8, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Cut” (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
- Failure to Cut1
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.
MalfunctionJul 8, 2022Failure to Cut; Failure to Cut
IT WAS REPORTED THAT ON (B)(6) 2022, THE HUMERAL NAIL 10.0MM CANNULATED AWL IS DULL AND WILL NOT CUT BATHY INTO BONE. IT IS ORIGINAL TO SET 10 PLUS YEARS. NO DELAY TO SURGERY AS SURGEON USED OPENING DRILL BIT ONCE REALIZING AWL TO DULL. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT CONSEQUENCE IS UNKNOWN. THIS REPORT IS FOR ONE (1) 10.0MM CANNULATED AWL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14961176 ↗
Other AWL devices
- Meridian RA2-003015Seaspine Orthopedics Corporation · AWL1 recall1 report
- AMP 117-165Alphatec Spine, Inc. · AWL1 recall0 reports
- SYNFIX Evolution 03.835.032Synthes GmbH · AWL16 reports
- NA 03.010.041Synthes GmbH · AWL7 reports
- ENDOSKELETON® TAS 2300-1110Medtronic Sofamor Danek, Inc. · AWL7 reports
- NA 359.213Synthes GmbH · AWL7 reports
- NA 03.820.100Synthes GmbH · AWL6 reports
- Endoskeleton™ TCS Interbody System 5210-1063Medtronic Sofamor Danek, Inc. · Awl5 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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