SIGMA LCS HIGH PERFORMANCE 9505-02-079Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10603295227908), received between Aug 22, 2018 and Sep 25, 2026 — classified as 61 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (36 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903850 ↗
• MalfunctionJul 30, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50084666 ↗
• MalfunctionJun 12, 2026Material Deformation

  IT WAS REPORTED THAT AN IM TIBIA DRILL WAS BENT. WHEN CONNECTED TO THE DRILL AND TURNED ON, THE BEND WOULD CAUSE THE DRILL TO SHAKE. DEVICE WAS DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491006 ↗
• MalfunctionJan 22, 2026Failure to Cut

  IT WAS REPORTED THAT DRILL IS DULL AND WILL NOT CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24145752 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS REPORTED A CHIPPED DRILL WAS DISCOVERED. IT IS UNKNOWN WHEN THE EVENT OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 22565141 ↗
• MalfunctionJul 1, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT REAMER WAS DULL AND WILL NOT CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372451 ↗
• MalfunctionJul 1, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT REAMER WAS DULL AND WILL NOT CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372403 ↗
• MalfunctionJan 15, 2025Break; Break

  IT WAS REPORTED THAT STEP DRILL WAS FOUND BROKEN WHEN CLEANING UP SETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158366 ↗
• MalfunctionNov 1, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2024. THE IM STEP DRILL TIP WAS DULL, HARD TO PENETRATE BONE TO PREPARE FOR DISTAL CUT.

  Patient problems: Insufficient Information

  MAUDE report 20586397 ↗
• MalfunctionOct 28, 2024Failure to Cut; Failure to Cut

  REAMERS ARE DULL AND NEED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20544044 ↗
• MalfunctionOct 28, 2024Failure to Cut; Failure to Cut

  REAMERS ARE DULL AND NEED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20544043 ↗
• MalfunctionOct 28, 2024Failure to Cut; Failure to Cut

  REAMERS ARE DULL AND NEED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20544037 ↗
• MalfunctionOct 28, 2024Failure to Cut; Failure to Cut

  REAMERS ARE DULL AND NEED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20544029 ↗
• MalfunctionOct 25, 2024Break; Break

  IT WAS REPORTED THAT THE DRILL IS BROKEN FROM ATTUNE. THERE WAS NO SURGICAL DELAY AND NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20535455 ↗
• MalfunctionJul 2, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE IM REAMER IS TOO DULL TO BREAK INTO BONE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19654398 ↗
• MalfunctionMar 28, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT SURGEON SAYS THE DRILL WAS DULL. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 18990303 ↗
• MalfunctionMar 8, 2024Failure to Cut; Failure to Cut

  ADDITIONAL INFORMATION WAS RECEIVED. THERE WERE NO ADVERSE CONSEQUENCES, NO DELAYS. THE COMPLAINT WAS, THE DRILL WAS DULL AND WOULD NOT CUT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18864670 ↗
• MalfunctionMar 7, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE DRILL WAS DULL AND WOULD NOT CUT INTRA OP. THERE WERE NO ADVERSE CONSEQUENCES, NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859507 ↗
• MalfunctionJan 11, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMERS ARE DULL. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498817 ↗
• MalfunctionJan 11, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMERS ARE DULL. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498812 ↗
• MalfunctionJan 11, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMERS ARE DULL. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498760 ↗
• MalfunctionJan 11, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMERS ARE DULL. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498749 ↗
• MalfunctionJan 11, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMERS ARE DULL. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498662 ↗
• MalfunctionJan 11, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMERS ARE DULL. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498474 ↗
• MalfunctionJan 11, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMERS ARE DULL. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498454 ↗