Arthrex® AR-1997Recalls & reported problems
Arthrex, Inc. · SCRWDRV SFT,CANN,FOR BIO-INT. SCRW · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867025738), received between Oct 18, 2017 and Oct 18, 2017 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Break1
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.
InjuryOct 18, 2017Break
IT WAS REPORTED THAT THE SCREWDRIVER BROKE AT THE LEVEL OF THE SCREW HEAD WHERE THE SCREW IS NORMALLY INSERTED. THE CENTRAL CORE OF THE SCREWDRIVER IS COMPLETELY BURIED IN THE SCREW AND NOT REMOVABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6958024 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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