CALIBRATED STEP DRILL 5.0mm S0209-200Recalls & reported problems
Advanced Orthopaedic Solutions, Inc. · 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 00848665000436), received between Feb 4, 2026 and Feb 4, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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.
Reports received per month
Most reported problems
Device problems
- Positioning Failure1
Patient problems
- Insufficient Information1
- 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.
MalfunctionFeb 4, 2026Positioning Failure
ON 08-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9094-090L LEFT LAG SCREW, AN AR-S0100-381 GUIDE PIN, AN AR-S0457-000 ACTIVATION TOOL, AR-S0100-000 GUIDE PIN, AR-S0219-100 DRILL, AR-S0209-200 DRILL, AR-9094-11-2030 TROCHANTERIC NAIL, AND AN AR-9094-085L LAG SCREW WERE USED IN A CASE AND NEITHER SCREW WERE ABLE TO LOCK INTO THE NAIL AFTER IMPLANTATION. ALL IMPLANTS WERE FULLY EXPLANTED AND THE SURGERY WAS COMPLETED USING A COMPETITOR PRODUCT NAIL. THIS OCCURRED DURING USE IN A CASE. DELAY IN CASE 50 MINUTES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24259068 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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