SIGMA LCS 9505-02-072Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE QUICK DRILL PINS · Class 1
All models of SIGMA LCS (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295227885), received between Mar 13, 2018 and Aug 23, 2022 — classified as 1 injury, 20 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (13 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.
Most reported problems
Device problems
- Material Twisted/Bent13
- Break6
- Material Deformation3
- Entrapment of Device1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Consequences Or Impact To Patient17
- No Clinical Signs, Symptoms or Conditions2
- Not Applicable2
- Foreign Body In Patient1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2022Entrapment of Device; Improper or Incorrect Procedure or Method; Entrapment of Device; Improper or Incorrect Procedure or Method
WE DID AN ATTUNE REVISION TUESDAY (B)(6) 2022. I WAS ALERTED BY THE SURGEON VIA TEXT, WITH XRAY IMAGES SHOWING A DRILL PIN IN THE FEMORAL CANAL. THE SURGEON THOUGHT THAT PERHAPS WHEN HE WAS SHIFTING THE CONVENTIONAL CUT GUIDE FROM LATERAL TO MEDIAL, THE MEDIAL PIN MUST HAVE FALLEN INTO THE CANAL UNNOTICED. HE ELECTED TO LEAVE THE PIN IN THE CANAL ONCE IT SHOWED ON XRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15275643 ↗MalfunctionDec 7, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING KNEE SURGERY TODAY THE BELOW PINS WERE BENT AND DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12953544 ↗MalfunctionMay 1, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE PIN WAS BENT DURING THE CASE AND DEEMED UNUSABLE BY THE SURGEON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8571075 ↗MalfunctionMar 1, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT PRIOR TO A SURGERY WHILE INSPECTING THE INSTRUMENTS, IT WAS NOTICED THAT 3 DRILL PINS WERE BENT. THESE WERE NOT USED IN THE SURGERY AND THE SURGERY WAS NOT DELAYED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8382232 ↗MalfunctionMar 1, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT PRIOR TO A SURGERY WHILE INSPECTING THE INSTRUMENTS, IT WAS NOTICED THAT 3 DRILL PINS WERE BENT. THESE WERE NOT USED IN THE SURGERY AND THE SURGERY WAS NOT DELAYED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8382218 ↗MalfunctionMar 1, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT PRIOR TO A SURGERY WHILE INSPECTING THE INSTRUMENTS, IT WAS NOTICED THAT 3 DRILL PINS WERE BENT. THESE WERE NOT USED IN THE SURGERY AND THE SURGERY WAS NOT DELAYED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8382150 ↗MalfunctionJan 11, 2019Material Twisted/Bent; Material Twisted/Bent
AS PER CUSTOMER THE PIN HAD A THREAD DAMAGE. ACCORDING TO HIS INFORMATION THIS PIN HAD TWO DIFFERENT THREAD FORMATIONS. SURGEON USED THIS PIN WITH THE RESULT THAT IN THE TRANSITION FROM ONE "THREAD PART" TO THE OTHER IN THE BONE THE CUTTING BLOCK WAS BROUGHT COMPLETELY OUT OF THE PLANNED POSITION. THE PIN WAS COMPLETELY BENT AT THAT MOMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8241090 ↗MalfunctionNov 6, 2018Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT TWO THREADED, NON-HEADED PINS WERE BENT OR BROKEN DURING SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8042058 ↗MalfunctionNov 6, 2018Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT TWO THREADED, NON-HEADED PINS WERE BENT OR BROKEN DURING SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8041932 ↗MalfunctionOct 15, 2018Break; Break
IT WAS REPORTED THAT THE TIBIA CUTTING BLOCK WAS FOUND WITH A HEADED DRILL PIN STUCK AND BROKEN INSIDE A PIN HOLE BEFORE THE CASE STARTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7966558 ↗MalfunctionOct 9, 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).
Patient problems: Not Applicable
MAUDE report 7946341 ↗MalfunctionSep 28, 2018Material Deformation; Material Deformation
THE DRILL PINS WERE BENT AFTER USING THEM ON FEMORAL JIG.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7919196 ↗MalfunctionSep 28, 2018Material Deformation; Material Deformation
THE DRILL PINS WERE BENT AFTER USING THEM ON FEMORAL JIG.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7919160 ↗MalfunctionSep 21, 2018Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRILL PINS WERE BENT WHEN PUTTING TIBIA JIG TOGETHER. SURGERY TIME WAS NOT DELAYED AND PINS ARE BEING RETURNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7897552 ↗MalfunctionSep 21, 2018Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRILL PINS WERE BENT WHEN PUTTING TIBIA JIG TOGETHER. SURGERY TIME WAS NOT DELAYED AND PINS ARE BEING RETURNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7897504 ↗MalfunctionAug 15, 2018Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DRILL PINS WERE BENT DURING ATTUNE TKA. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7784502 ↗MalfunctionAug 15, 2018Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DRILL PINS WERE BENT DURING ATTUNE TKA. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7784500 ↗MalfunctionAug 15, 2018Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DRILL PINS WERE BENT DURING ATTUNE TKA. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7784498 ↗MalfunctionAug 15, 2018Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DRILL PINS WERE BENT DURING ATTUNE TKA. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7784481 ↗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 7682742 ↗InjuryMar 13, 2018Break; Break
DURING SURGERY ON THE (B)(6) 2018, A DRILL PIN BROKE AND COULD NOT BE RETRIVED FROM THE PATIENT AND SO WAS LEFT IN PLACE. MR (B)(6) WAS THE SURGEON ON THE DAY. THE PIN WAS LEFT IN PLACE AS IT DID NOT AFFECT THE IMPLANT PLACEMENT. PART OF THE PIN WAS LEFT IN THE PATIENT, THE OTHER HALF WAS THROWN AWAY. IT WAS DEEMED NOT TO AFFECT THE IMPLANTATION OR PATIENT RECOVERY.
Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient
MAUDE report 7333931 ↗
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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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