SIGMA 2024-71-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295083795), received between Jan 20, 2019 and Feb 4, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE CHISEL BIKE WAS INSIDE THE CUT BLOCK. CHISEL PIER IS STUCK IN THE IT BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258891 ↗
• MalfunctionApr 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PUNCH THAT GOES THROUGH CUTTING BLOCKS GETS STUCK IN TWO OF THE BLOCKS. NO PIECES BROKE OFF, JUST GETS STUCK WHEN YOU INSERT THE PUNCH IN THE CUTTING BLOCKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153342 ↗
• MalfunctionJan 22, 2021Break; Mechanical Jam; Break; Mechanical Jam

  CHISEL BROKE IN CUT BLOCK. CAN¿T GET THE BROKEN PIECE OUT OF BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11217398 ↗
• MalfunctionJan 22, 2021Break; Mechanical Jam; Break; Mechanical Jam

  CHISEL BROKE IN CUT BLOCK. CAN¿T GET THE BROKEN PIECE OUT OF BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11217293 ↗
• MalfunctionJan 18, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DURING A PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2021 USING SIGMA UNICOMPARTMENTAL KNEE INSTRUMENTS: THE ANTERIOR CHISEL AND THE FEMORAL FINISHING BLOCK SZ 5 INTERLOCKED AND COULD NOT BE DISASSEMBLED. THERE WAS A SURGICAL DELAY OF 5 MINUTES. NO PATIENT CONSEQUENCES REPORTED AND THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING THE SMALLER FEMORAL CUTTING BLOCK. DOE: (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 11187798 ↗
• MalfunctionDec 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  INTRODUCTION OF CHISEL TO BLOCK, LIGHTLY IMPACTED TO ADVANCE. CHISEL GOT STUCK IN THE BLOCK, UNABLE TO REMOVE. CHISEL HANDLE SEPARATED AND BROKEN. UNABLE TO REMOVE THE REMAINING PIECE OF CHISEL IN BLOCK DURING SURGERY. ATTEMPTED TO REMOVE MINOR PIECE OF CHISEL, MINOR DELAY EXPERIENCED, 5 MINS. BLOCK REMOVED, UPSIZED TO A 5-6 FEMORAL BLOCK AND IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 10944462 ↗
• MalfunctionJan 20, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CHISEL GOT STUCK IN SLOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8263221 ↗