SIGMA 9505-01-222Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295225270), received between Jan 27, 2021 and Sep 11, 2023 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIGHTENING KNOB BROKE OFF INTRODUCER. AP SIZER DOESN'T SLIDE PROPERLY. TIB CUT BLOCK HAS STRETCHED.

  Patient problems: Insufficient Information

  MAUDE report 17725713 ↗
• MalfunctionMay 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIN WAS STUCK IN THE TIBIAL CUT BLOCK. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952059 ↗
• MalfunctionJun 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  PIN WILL NOT GO THROUGH ONE OF THE TIBIAL BLOCK HOLES. SURGICAL DELAY OF 2 MINUTES OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 14844917 ↗
• MalfunctionSep 24, 2021Break; Break

  EMAIL RECEIVED FROM CSSD ORTHO TECH WITH A LIST OF BROKEN INSTRUMENTS. THE LIST CONTAINS ONLY INSTRUMENTS THAT ARE BROKEN WITH CODES OF THE INSTRUMENTS. NO DESCRIPTION OF DAMAGE OR HOW THE DAMAGE HAS OCCURED ONLY THAT THE INSTRUMENTS ARE BROKEN. THIS IS TO BE FOLLOWED UP BY MYSELF. THE DATE OR DAY OF EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12527144 ↗
• MalfunctionJan 27, 2021Material Deformation; Material Deformation

  INFORMED BY ORTHOTECH OF A SHARP EDGE ON TIBIAL CUTTING BLOCK, BLADE ALIGNMENT WON¿T BE AFFECTED BUT THEY WOULD STILL LIKE IT REPLACED. TIBIAL BLOCK IS PART OF THEIR CONSIGNED KITS, IT¿S BEEN TAGGED. WA WAREHOUSE HAVE ORDERED A NEW TIBIAL CUTTING BLOCK WHICH WILL BE SWAPPED OUT NEXT WEEK, UNTIL THEN THEY HAVE IT IN A MARKED TRAY AS A DROP SET IN CASE OF AN EMERGENCY AS THERE ARE LOTS OF CASES NEXT WEEK. I AM NOT SURE IF IT HAPPENED INTRA/POST-OP. FOR THE PURPOSE OF THIS PC I HAVE PUT DOWN THE NAME OF THE SURGEON THAT I REGULARLY WORK WITH AT FREMANTLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11238618 ↗