Ø4.0mm DISTAL DRILL GUIDE, LOCKING 0315-100Recalls & reported problems
Advanced Orthopaedic Solutions, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665001440), received between Dec 1, 2023 and Aug 27, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Positioning Failure
On (b)(6) 2026, it was reported by a sales Representative via (b)(6) that a 1268-100 targeting arm and 0315-100 drill guide are no longer targeting. Noticed during a case with no patient effect.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50473398 ↗MalfunctionDec 1, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
ON 11/01/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 0315-100 4.0MM DISTAL DRILL GUIDE HAD A DRILL BECOME STUCK AND LOCKED IT COMPLETELY SEIZED UP. THIS OCCURRED DURING A CASE, WITH NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18248210 ↗
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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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