P.F.C. SIGMA 96-1430Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295238232), received between Mar 22, 2018 and Apr 15, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionApr 15, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE INTO TWO PIECES AND DISPOSED OF. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111044 ↗
• MalfunctionDec 3, 2020Break; Break

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA TKA FOR THE PATIENT'S RIGHT KNEE JOINT. IT WAS REPORTED DURING THE SURGERY, WHEN THE SURGEON REMOVED THE TIBIAL INSERT TRIAL WITH ELEVATOR, THE TRIAL BROKE. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE WITHOUT ANY SURGICAL DELAY. THE SURGEON CHECKED NO FRAGMENT IN THE BODY. THE SURGEON COMMENTED THAT HE TRIED TO REMOVE THE TRIAL FORCIBLY, SO THE TRIAL BROKE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10940997 ↗
• MalfunctionMar 22, 2018Break; Break

  IT WAS REPORTED THAT 2.5 X 8, 10 MM INSERT TRIALS BROKE. LIP THAT SITS IN TRAY ON BOTH. ALL PIECES RETRIEVED. SURGERY NOT DELAYED. TRIALS THROWN AWAY BY CPD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7362170 ↗