RETROGRADE TARGETING GUIDE 1280Recalls & reported problems
Advanced Orthopaedic Solutions, Inc. · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00848665017038), received between Oct 11, 2022 and Jul 30, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (5 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break5
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2025Break; Break
ON 07/08/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN 1280-000 RETROGRADE TARGETING GUIDE SNAPPED OFF. THIS OCCURRED DURING A RETROGRADE NAIL CASE (B)(6) 2025. THE SMALL TINES THAT HELP CONNECT THE NAIL TO THE TARGETING GUIDE SNAPPED OFF. MULTIPLE PICTURES SHOWING THE ITEM NUMBER OF THE TARGETING GUIDE AND THE PIECES WERE ABLE TO BE FOUND. THE SURGERY WAS ABLE TO BE COMPLETED BY USING ANOTHER TARGETING GUIDE.
Patient problems: Insufficient Information
MAUDE report 22665314 ↗MalfunctionJun 27, 2025Break; Break
ON 06/05/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1280-000 RETROGRADE TARGETING GUIDE BROKE OFF INSIDE THE PATIENT WHERE THE NAIL ATTACHED. THE BROKEN PIECES WERE RETRIEVED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22347098 ↗MalfunctionMar 18, 2024Break; Break
ON 02/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 1280-000 TARGETING GUIDE AND A 1281-000 TARGETING GUIDE BROKE. DEBRIS WAS ABLE TO BE RECOVERED FROM THE PATIENT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18923752 ↗MalfunctionSep 19, 2023Break; Break
ON 08/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A 1280-000 RETROGRADE TARGETING GUIDE BROKE. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17775187 ↗MalfunctionOct 11, 2022Break
ON 09/20/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A 1280-000 TARGETING GUIDE TEETH BROKE OFF. THIS OCCURRED ON (B)(6) 2022 DURING A RETROGRADE FEMORAL NAIL WHEN THE TEETH BROKE OFF WHERE IT ENGAGES IN THE NAIL FOR INSERTION. THERE WAS NO PATIENT EFFECT REPORTED, AND NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Insufficient Information
MAUDE report 15575508 ↗
Other Orthopedic Manual Surgical Instrument devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.