SIGMA LCS HIGH PERFORMANCE 9505-02-302Recalls & reported problems
Depuy (Ireland) · SIGMA LCS HIGH PERFORMANCE INSTRUMENTS STERILE THREADED PINS · Class 1
All models of SIGMA LCS HIGH PERFORMANCE (6)
Data updated Oct 16, 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 10603295228905), received between Aug 11, 2020 and Aug 11, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
- Physical Resistance/Sticking1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking
IT WAS REPORTED THAT A THREADED PIN WAS INCARCERATED IN AN ATTUNE TIBIA CUT BLOCK AND BROKEN INTO TWO PIECES. ONE PIECE STAYED INSIDE PIN DRIVER AND SECOND SIDE WAS STUCK IN CUT BLOCK. SLIGHT DELAY TO GET BLOCK OFF PATIENT BY CUTTING PIN AND UNSCREWING MANUALLY. NO PATIENT HARM.
Patient problems: No Code Available
MAUDE report 10390712 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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