ANTEGRADE TARGETING MODULE FEMORAL NAIL SYSTEM 1271-300Recalls & reported problems
Advanced Orthopaedic Solutions, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848665034073), received between Oct 5, 2023 and May 15, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (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
- Crack1
- Defective Device1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2025Defective Device; Defective Device
ON 04/21/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1271-300 TARGETING MODULE DID NOT LINE UP AND WAS MISSING THE SCREW HOLE IN THE NAIL BY AT LEAST 6MM. WE WERE ABLE TO COMPLETE THE CASE WITH A FREEHAND LOCK. DELAYED US BY ABOUT 10 MINUTES AFTER WHICH THE CASE WAS COMPLETED WITHOUT ISSUE. NO ADVERSE PATIENT ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22029708 ↗MalfunctionDec 29, 2023Unintended Movement; Unintended Movement
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(46.THAT A 1271-300 ANTEGRADE TARGETING MODULE HAD AN ISSUE WITH THE SCREW SHEATH BEING LOOSE ON THE JIG AND THEREFORE MISSING THE NAIL IMPLANT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED ADVERSE EVENT OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18419657 ↗MalfunctionOct 5, 2023Crack; Crack
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06023480 THAT AN 1271-200 TARGETING MODULE HAS A CRACK IN THE JIG AND THE BOLT THAT HOLDS THE JIG IS LOOSE. WHEN THE NAIL IS FULLY TIGHTENED ONTO THE JIG, THERE IS NO POSITIVE STOP, WHICH THEN CREATES THE NAIL TO BEGIN ROTATING WHILE THE NAIL IS ATTACHED. THIS WAS DISCOVERED DURING A CASE, WITH NO ADVERSE EFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17876840 ↗
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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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