GUIDE PIN 3.2mm x 330mm S0100-000Recalls & reported problems
Advanced Orthopaedic Solutions, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665000009), received between Feb 4, 2026 and Apr 27, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
- Positioning Failure1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT AFTER THE INITIAL SURGERY ON (B)(6) 2026, A REVISION SURGERY WAS PERFORMED ON THE SAME DAY BECAUSE A LEFT TROCHANTERIC NAIL HAD BEEN MISTAKENLY IMPLANTED INSTEAD OF THE RIGHT TROCHANTERIC NAIL. THE REVISION SURGERY WAS FINISHED SUCCESSFULLY USING THE RIGHT TROCHANTERIC NAIL. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE. UPDATE 15-APR-2026 - FURTHER INFORMATION WAS RECEIVED: THE DISTRIBUTOR REPORTED THAT THE LABEL OF THE DEVICE WAS CORRECT. THE INCIDENT WAS CAUSED BY AN ERROR AT THE HOSPITAL. NO X-RAYS ARE AVAILABLE. THE INITIAL SURGERY AND THE REVISION SURGERY WERE PERFORMED IN THE SAME HOSPITAL THROUGH THE SAME SURGEON.
Patient problems: Insufficient Information
MAUDE report 25002290 ↗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 24259242 ↗
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- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- 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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