SIGMA 2011-03-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295081234), received between Mar 12, 2019 and Nov 8, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2019Difficult to Remove; Device-Device Incompatibility; Physical Resistance/Sticking; Difficult to Remove; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER INSERTING A HEADED PIN THROUGH THE TC3 4 IN 1 BLOCK, THE PIN GOT STRUCK THROUGH THE BLOCK AND DISTAL SPACER AND COULD NOT BE REMOVED, BOTH DURING AND AFTER THE CASE. WITH 20 MINUTES SURGICAL DELAY.

  Patient problems: Not Applicable

  MAUDE report 9297438 ↗
• MalfunctionOct 25, 2019Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PIN GOT STUCK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240730 ↗
• MalfunctionMar 12, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SIZE 3 CUTTING BLOCK PINS HOLES DON¿T LET PINS PASS THROUGH.

  Patient problems: Not Applicable

  MAUDE report 8412943 ↗