SIGMA LCS 9505-02-088Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE THREADED PINS · Class 1
All models of SIGMA LCS (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295227915), received between Jan 22, 2018 and Sep 5, 2025 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Component Missing” (9 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. 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
- Component Missing9
- Break3
- Detachment of Device or Device Component3
- Material Deformation3
- Material Twisted/Bent3
Patient problems
- No Consequences Or Impact To Patient14
- No Clinical Signs, Symptoms or Conditions4
- Not Applicable1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE THREADED PIN WAS WITHOUT STOPPER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22983569 ↗MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ATTUNE PIN PACK WAS MISSING THE 2 X THREADED HEADED AND 2 X THREADED HEADLESS PINS. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21229565 ↗MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ATTUNE PIN PACK WAS MISSING THE 2 X THREADED HEADED AND 2 X THREADED HEADLESS PINS. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21229522 ↗MalfunctionSep 6, 2022Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING KNEE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15363236 ↗MalfunctionAug 18, 2020Material Twisted/Bent; Material Twisted/Bent
THREADED PIN WAS DAMAGED DURING THE PROCEDURE. NO HARM TO THE PATIENT. PRODUCT: (B)(4). LOT: UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10420179 ↗MalfunctionOct 23, 2018Component Missing; Material Twisted/Bent; Component Missing; Material Twisted/Bent
PINS WERE NOTED TO BE MISSING AND/OR BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7994989 ↗MalfunctionOct 23, 2018Component Missing; Material Twisted/Bent; Component Missing; Material Twisted/Bent
PINS WERE NOTED TO BE MISSING AND/OR BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7994975 ↗MalfunctionOct 16, 2018Component Missing; Component Missing
THE PINS WERE NOTED TO BE MISSING AND/OR BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7971139 ↗MalfunctionOct 16, 2018Component Missing; Component Missing
THE PINS WERE NOTED TO BE MISSING AND/OR BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7971109 ↗MalfunctionOct 16, 2018Component Missing; Component Missing
THE PINS WERE NOTED TO BE MISSING AND/OR BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7971072 ↗MalfunctionOct 16, 2018Component Missing; Component Missing
THE PINS WERE NOTED TO BE MISSING AND/OR BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7971041 ↗MalfunctionOct 16, 2018Component Missing; Component Missing
THE PINS WERE NOTED TO BE MISSING AND/OR BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7971002 ↗MalfunctionOct 16, 2018Component Missing; Component Missing
THE PINS WERE NOTED TO BE MISSING AND/OR BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7970975 ↗MalfunctionOct 16, 2018Component Missing; Component Missing
THE PINS WERE NOTED TO BE MISSING AND/OR BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7970952 ↗MalfunctionOct 16, 2018Material Deformation; Material Deformation
THE PINS WERE NOTED TO BE MISSING AND/OR BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7970922 ↗MalfunctionOct 16, 2018Material Deformation; Material Deformation
THE PINS WERE NOTED TO BE MISSING AND/OR BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7970837 ↗MalfunctionOct 16, 2018Material Deformation; Material Deformation
THE PINS WERE NOTED TO BE MISSING AND/OR BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7970730 ↗MalfunctionJul 12, 2018Break; Break
DURING THE SURGERY ONE OF THE PINS (HP QUICK DRILL PINS, 950502072 OR HP THREADED PINS, 950502088) SNAPPED AND BROKE IN THE SIGMA HP POWER PIN DRIVER (9505-02-071). THIS REMAINED IN THE PIN DRIVER AND THEREFORE THE PIN DRIVER COULD NOT BE USED DURING THE REMAINDER OF THE CASE. AS A RESULT, PLEASE DO NOT CHARGE THE HOSPITAL FOR ONE MISSING A PIN OR THE PIN DRIVER DAMAGE AS THIS HAPPEN DURING USE. I AM UNAWARE OF WHICH KIT THE MISSING PIN AND DAMAGE TO THE PIN DRIVER OCCURRED, THEREFORE PLEASE CAN THIS BE NOTED ON BOTH BOOKINGS.
Patient problems: Not Applicable
MAUDE report 7682755 ↗MalfunctionJan 22, 2018Break; Break
INTRAOPERATIVELY BOTH INSTRUMENTS GOT STUCK. OTHER INSTRUMENTS WERE AVAILABLE. PROCEDURE WAS FINISHED WITH ABOUT 5 MINUTES OF SURGERY DELAY. NO ADVERSE CONSEQUENCES FOR PATIENT OR USER. THERE WAS A SURGICAL DELAY OF 5 MINUTES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7209284 ↗
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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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