NA 324.077Recalls & reported problems
Synthes (U.S.A.) LP · AWL · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034769240), received between Jul 18, 2022 and Jul 18, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Entrapment of Device2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2022Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED ON (B)(6) 2022, THAT THEY WERE USING AN AWL FROM THAT SYSTEM AND THE TIP OF AWL, TINY SMALL AMOUNT OF THE OLD TIP BROKE OFF WHILE WE WERE MALLEATING IT. THEY DIDN¿T NOTICE IT UNTIL THE TIP OF SCREW AND THEN WHEN THEY REALIZED THE TIP WAS DAMAGED AND THEY REALIZED THAT IT¿S STILL IN THE BONE. SURGEON LEFT IT IN THERE. THE TIP OF THE AWL REMAIN INSIDE THE PATIENT¿S BONE AND SCREW ON TOP OF IT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) AWL. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 15043119 ↗InjuryJul 18, 2022Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED ON (B)(6) 2022, THAT THEY WERE USING AN AWL FROM THAT SYSTEM AND THE TIP OF AWL, TINY SMALL AMOUNT OF THE OLD TIP BROKE OFF WHILE WE WERE MALLEATING IT. THEY DIDN¿T NOTICE IT UNTIL THE TIP OF SCREW AND THEN WHEN THEY REALIZED THE TIP WAS DAMAGED AND THEY REALIZED THAT IT¿S STILL IN THE BONE. SURGEON LEFT IT IN THERE. THE TIP OF THE AWL REMAIN INSIDE THE PATIENT¿S BONE AND SCREW ON TOP OF IT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) AWL. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 15043057 ↗
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 359.213Synthes GmbH · AWL7 reports
- NA 03.010.041Synthes GmbH · AWL7 reports
- ENDOSKELETON® TAS 2300-1110Medtronic Sofamor Danek, Inc. · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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