SIGMA 96-6202Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295247272), received between Nov 15, 2017 and Jan 5, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE LUG HOLE IN FEMUR IS BURNISHED AND CAUSED LUG DRILL TO BIND. KEEL PUNCH WOULD NOT STAY ON HANDLE. NO BROKEN PIECES. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13169741 ↗
• MalfunctionNov 7, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE FEMORAL LUG DRILL WAS DULL AND BINDING UP WITH THE FEMORAL TRIAL. INSTRUMENTATION DID NOT BREAK. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758352 ↗
• MalfunctionSep 29, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE LUG DRILLS ARE DULL FROM REGULAR USE.

  Patient problems: Insufficient Information

  MAUDE report 12546959 ↗
• MalfunctionSep 29, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE LUG DRILLS ARE DULL FROM REGULAR USE.

  Patient problems: Insufficient Information

  MAUDE report 12546958 ↗
• MalfunctionSep 29, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE LUG DRILLS ARE DULL FROM REGULAR USE.

  Patient problems: Insufficient Information

  MAUDE report 12546957 ↗
• MalfunctionSep 29, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE LUG DRILLS ARE DULL FROM REGULAR USE.

  Patient problems: Insufficient Information

  MAUDE report 12546956 ↗
• MalfunctionAug 5, 2021Break; Entrapment of Device; Material Deformation; Break; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT THE BARB ON THE LUG HOLE CAUSED METAL DEBRIS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12279991 ↗
• MalfunctionJul 27, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE DRILL WAS BLUNT AND DIDN¿T DRILL WELL ENOUGH INTO BONE. PROCEDURE COMPLETED SUCCESSFULLY AFTER A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233573 ↗
• MalfunctionJul 22, 2020Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  IT WAS REPORTED THAT THE LUG DRILL IS DULLED AND NOT CUTTING PATELLA TRIAL IS MISSING A PEG THAT SHEARED OFF. THE SIZE POLY TRIALS ARE FADED AND SIZES AREN¿T ABLE TO BE READ OR DISTINGUISHED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10308855 ↗
• MalfunctionMar 8, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  THE OFFICE SETS INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. IT DID NOT AFFECT SURGERY OR PATIENT. EXAMINATION OF THE RETURNED DEVICE BY THE PRODUCT ANALYST FOUND THE CUTTING FLUTES OF THE DEVICE TO BE DAMAGED/WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8405071 ↗
• MalfunctionAug 27, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SIGMA LUG DRILL IS WORN DOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818656 ↗
• MalfunctionNov 15, 2017Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT THE DRILL IS ROUNDED OFF AND HAS NOTCHES.

  Patient problems: No Information

  MAUDE report 7034221 ↗