P.F.C. SIGMA 96-1341Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295237129), received between Nov 26, 2017 and Jun 2, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2022Break; Break

  IT WAS REPORTED THAT THE PLASTIC ON THE POLY TRIALS PEELED WHILE DOING TRIAL REDUCTION. SURGICAL DELAY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14581977 ↗
• MalfunctionJan 17, 2022Break; Break

  TIBIAL INSERT IS BROKEN ON THE TRIAL. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266515 ↗
• MalfunctionSep 10, 2021Break; Crack; Break; Crack

  (B)(4). IT WAS REPORTED THAT THE SIZE 2.5 10MM FB CVD SIGMA INSERT CRACKED AND BROKE INTO 2 PIECES. ALL PIECES RETRIEVED. PLEASE SEND A REPLACEMENT TO OUR KNOXVILLE OFFICE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12454125 ↗
• MalfunctionAug 27, 2021Break; Break

  IT WAS REPORTED THAT THE POLY TRIAL WAS FLAKING OFF ON TRIAL REDUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378473 ↗
• MalfunctionJun 21, 2019Break; Break

  IT WAS REPORTED THAT THE SZ 2.5 10 MM SIGMA CVD POLY BROKE WHILE BEING REMOVED WITH AN OSTEOTOME. NO SURGICAL DELAY HAPPEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8724109 ↗
• MalfunctionApr 30, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT SIGMA CVD INS TR SZ 2.5 10MM, PRODUCT CODE 961341 BROKE DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8564417 ↗
• MalfunctionNov 29, 2018Naturally Worn; Naturally Worn

  TRIALS ARE WORN AND CHIPPED THROUGH MULTIPLE USE, HOSPITAL ARE NOT PREPARED TO RE STERILISE.

  Patient problems: No Code Available

  MAUDE report 8117157 ↗
• MalfunctionNov 26, 2017Break; Break

  IT WAS REPORTED THAT THE POLY TRIAL WAS BROKEN. NO SURGICAL DELAY. NO PIECES LEFT IN PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7058169 ↗