SIGMA LCS HIGH PERFORMANCE 9505-02-071Recalls & reported problems

Summary

The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 10603295227878), received between Jun 27, 2017 and Sep 24, 2026 — classified as 137 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (82 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

Recent adverse event reports

The 25 most recent of 137 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break; Device-Device Incompatibility

  It was reported that threaded pin broke and got stuck in sz 6 right cut through trial. Need to replace pin driver and cut through trial.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882680 ↗
• MalfunctionJul 28, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50052083 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT THE PIN DRIVER WAS BROKEN. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506902 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT THE PIN DRIVER HAD A BROKEN OFF PIN WEDGED INSIDE RENDERING IT UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146672 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT THE PIN HEAD BROKEN OFF IN DRIVER DURING REMOVAL OF PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23929695 ↗
• MalfunctionNov 5, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE THE PIN BROKE INSIDE THE PIN DRIVER. UNABLE TO TAKE THE BROKEN PIN INSIDE THE PIN DRIVER. USED ANOTHER SET. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480380 ↗
• MalfunctionAug 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PIN DRIVER COULD NOT SUCCESSFULLY ATTACH TO CORRECT POWER CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893166 ↗
• MalfunctionAug 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SPRING ON SPACER BLOCK IS DAMAGED AND PIN DRIVER WILL NOT HOLD PIN. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771405 ↗
• MalfunctionJul 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIN SNAPPED OFF INSIDE THE DRIVER AND COULD NOT BE TAKEN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642974 ↗
• MalfunctionJun 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENT WOULD NOT FIT PROPERLY ON QUICK CHUCK. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292612 ↗
• MalfunctionMay 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIN DRIVER WILL GO IN THE HUDSON BUT IS VERY DIFFICULT TO REMOVE. ONE PEG ON THE BOTTOM OF THE POLY TRIAL SNAPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103594 ↗
• MalfunctionMay 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DRIVER STRIPPED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055541 ↗
• MalfunctionMay 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DRIVER STRIPPED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055498 ↗
• MalfunctionMay 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DRIVER STRIPPED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22053942 ↗
• MalfunctionMay 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DRIVER STRIPPED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22053767 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT THE FEMUR SIZER BROKE DURING SURGERY. A PIN TIP BROKE INSIDE THE PIN ADAPTER REF. THE SURGERY WAS DELAYED 15 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961167 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE THREADED HEADED PIN WAS SNAPPED OFF IN THE DRIVER.

  Patient problems: Insufficient Information

  MAUDE report 21585230 ↗
• MalfunctionJan 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: IS THERE ANY ALLEGATION PRESENT AGAINST THE ATTUNE PINS? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266368 ↗
• MalfunctionJan 8, 2025Device-Device Incompatibility; No Apparent Adverse Event; Device-Device Incompatibility; No Apparent Adverse Event

  THREADED HEADED ATTUNE PIN HEAD SNAPPED OFF INSIDE THE HP PIN DRIVER. IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED SUCCESSFULLY OR DELAYED. IT WAS ALSO UNKNOWN IF THERE WERE FRAGMENTS GENERATED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103110 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT THE PIN DRIVERS BROKE.

  Patient problems: Insufficient Information

  MAUDE report 21094129 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT THE PIN DRIVERS BROKE.

  Patient problems: Insufficient Information

  MAUDE report 21094122 ↗
• MalfunctionJan 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ATTUNE PIN DRIVER WOULD NOT CONNECT TO THE HUDSON ADAPTER AND NEEDED REPLACEMENT. THE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085652 ↗
• MalfunctionNov 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DRILL PINS GET JAMMED IN THE HP POWER PIN GUIDE AND DO NOT RELEASE THE PIN NEEDS TO BE RELEASED, BUT IT DOES NOT PERFORM THIS FUNCTION. THERE WAS FIVE (5) MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685583 ↗
• MalfunctionOct 11, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: THE ACCOUNT DISCARDED THE ITEM AND ALL THE INFORMATION I WAS TOLD WAS THAT IT WAS NOT ENGAGING PINS PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433576 ↗
• MalfunctionSep 16, 2024Device-Device Incompatibility; No Apparent Adverse Event; Device-Device Incompatibility; No Apparent Adverse Event

  ADDITIONAL INFORMATION STATES THAT DURING THE VISUAL EXAMINATION PERFORMED ON (B)(6) 2024, IT WAS FOUND THAT THE DEVICE (UNK FIXATION PIN) WAS JAMMED/SEIZED WITH THE TIBIAL BLOCK.

  Patient problems: Insufficient Information

  MAUDE report 20224915 ↗