SIGMA 9505-01-225Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295225300), received between Nov 20, 2017 and May 22, 2025 — classified as 7 malfunctions.

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

• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT THE PIN BROKE INTO CUTTING BLOCK WHILE RECUTTING THE TIBIA. EXTRA TRAY WAS OPENED FOR ANOTHER BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22068720 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT THERE WERE FALLING FILINGS FROM THE CUTTING BLOCK DURING HANDLING DURING THE KNEE REPLACEMENT PROCEDURE. THE FILINGS WERE REMOVED EASILY FROM THE SURGICAL FIELD WITHOUT REQUIRING ADDITIONAL INTERVENTION, AND THE CUTTING GUIDE WAS CHANGED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264099 ↗
• MalfunctionJun 6, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT IT WAS FOUND THAT THE HOLE OF THE TIBIAL CUTTING BLOCK (P/N: 950501225) FOR CONNECTING WAS ALREADY DISTORTED AND IT WAS NOT ABLE TO CONNECT WHEN IT WAS CHECKED UP INSTRUMENTS ON THE DAY BEFORE SURGERY ON (B)(6) 2019. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8675113 ↗
• MalfunctionMay 2, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIAL ALIGNMENT GUIDE WOULD NOT FIT IN ANTERIOR SLOTS OF CUTTING BLOCK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8575125 ↗
• MalfunctionFeb 7, 2018Device Issue; Device Issue

  DER STATES THAT THE SCRUB TECH WAS UNABLE TO CONNECT THE CUTTING BLOCK TO THE TIBIAL ALIGNMENT JIG. NO SURGICAL DELAY. ALL PIECES WERE RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7247099 ↗
• MalfunctionDec 13, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  POOR CUTTING ACCURACY. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 7112461 ↗
• MalfunctionNov 20, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE TIBIAL CUTTING BLOCK WORN STYLUS LOOSE IN CUTTING BLOCK.

  Patient problems: No Information

  MAUDE report 7046464 ↗