SIGMA 2024-71-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295083771), received between May 11, 2018 and Feb 4, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Material Deformation

  IT WAS REPORTED THAT CUT BLOCK IS BENT AND SAW WILL NOT FIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258842 ↗
• MalfunctionDec 26, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT A PROTRUDING METAL PIECE PREVENTED THE SAW BLADE FROM DESCENDING INTO THE CUTTING BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896752 ↗
• MalfunctionMar 4, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. AFTER ALL THE FEMORAL PREP WAS DONE, CHISEL PREP COMMENCED. WHEN IMPACTING OUT, THE CHISEL GOT STUCK AND SNAPPED INSIDE THE FEMORAL CUTTING BLOCK. THE BROACH CORAIL AMT 12 WAS BROKEN. ALL FRAGMENTS WERE RETRIEVED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517789 ↗
• MalfunctionNov 13, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO USE CHISEL IN CUTTING BLOCK AS PER OPERATION TECHNIQUE BUT RECOGNIZED 2X CUTTING BLOCKS WERE FAULTY AND USED ALTERNATIVE METHOD AS SUGGESTED IN OPTECH. IT WAS CONFIRMED THAT CUTTING BLOCKS ARE DAMAGED BEYOND STATE OF ADEQUATE AND APPROPRIATE USE. THE NOTCH WHERE THE CHISEL IS INSERTED IS DAMAGED, PREVENTING THE CHISEL FROM ENTERING. THE DAMAGED ASPECT IS THE SMALL PROTRUDING METAL PIECE WITHIN THE CHISEL SLOT. THE CHISEL HAS A RAISED ASPECT THAT IS DESIGNED TO RUN ALONG THE PROTRUDING METAL PIECE. IN BEING DAMAGED, THIS IS PREVENTING ACCESS. THERE WAS NO HARM TO THE PATIENT. THE SURGEON RECOGNIZED DAMAGED AND USED ALTERNATIVE APPROACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20673463 ↗
• MalfunctionAug 11, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE ANTERIOR CHISEL BROKE AND GOT STUCK IN THE CUTTING BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515227 ↗
• MalfunctionMay 11, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE SIZE 3 FEMORAL UNI BLOCK WAS USED AND 1/8 PIN GOT STUCK AND STRIPPED HOLE IN BLOCK. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507004 ↗