SIGMA 2011-03-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295081241), received between Aug 8, 2017 and Jun 8, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE TRYING TO REMOVE THE PIN OUT OF THE SIZE 4 TC3 FEMORAL CUTTING BLOCK, THE PIN GOT STUCK AND CAUSED DAMAGE TO THE INSIDE HOLE OF THE CUTTING BLOCK. CASE WAS FINISHED OKAY AND WITHOUT ANY PROBLEMS OR DELAYS. JUST NEED BLOCK REPLACED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958828 ↗
• MalfunctionJul 22, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREW WILL NOT PASS THROUGH SCREW HOLE IN SIZE 4, 4-IN-1 CUTTING BLOCK AND NOTCH CUTTING GUIDE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10309034 ↗
• MalfunctionMar 12, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SURGEON WAS DRIVING THE PIN INTO THE TC3 SIZE 4 CUTTING BLOCK AND THROUGH THE AUGMENT WHEN THE PIN BENT AND GOT BOUND UP BREAKING THE PIN HEAD OFF INTO THE PIN DRIVER AND BENDING THE PIN AT THE SAME TIME.

  Patient problems: Not Applicable

  MAUDE report 8412684 ↗
• MalfunctionAug 8, 2017Disassembly; Difficult to Remove; Connection Problem; Disassembly; Difficult to Remove; Connection Problem

  IT WAS REPORTED THAT A HEADED PIN GOT STUCK INSIDE A SIZE 4 HP REVISION 4 IN 1 CUTTING BLOCK WITH 8 MM AUGMENT ON IT. PULLED PIN FROM BONE WITH PLYERS.

  Patient problems: No Information

  MAUDE report 6773200 ↗